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Distal Femur Cemented Modular Prosthesis Failure Causing a Medical Device-Related Adverse Event: A Report of a Rare
Arohi Agarwal1,2, Krishna Singh3, Samyak Jain1,2
1Materiovigilance, All India Institute of Medical Sciences Rishikesh, Rishikesh, IND.
Abstract:
A distal femoral cemented modular prosthesis is a viable option for post-bone tumor and limb salvage procedures. The major reasons for implant failures are the poor quality of implants, mechanical stress, biochemical reactions, and extended period of the implant in vivo use. Rare incidences have been reported of distal femur prosthesis implant malfunctioning in a subject having osteosarcoma. Common adverse events associated with implant failure include surgical site infections, swelling, pain, revision of the surgical procedure, cyst formation, and build-up of metal debris on soft tissues. Our case report summarizes gross malfunctioning of a distal femur cemented modular prosthesis experienced by a 24-year-old post-operated osteosarcoma patient who developed excruciating sudden pain and the inability to bear weight on the right leg, with the sudden onset of these symptoms developing while turning in bed.

