MAUDE Adverse Event Report: EXACTECH, INC. PS CEMENTED FEMORAL SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	PS CEMENTED FEMORAL SZ 3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, 20 years postop the initial implant (bilateral knees), this (b)(6) y/o female patient had a right poly/patella revision.The reason was not reported.The insert was removed, and the femur was removed with 15-20 moderate taps with a light mallet.The tibia had to be removed with revision saw blade and a moderate amount of work.The rep asked to be allowed to take pictures of the retrievals and surgeon agreed.No pictures of the patient¿s bone were allowed.The femur after being prepped for implants was excellent for a 20-year-old primary knee.The rep estimated there was 2cm of purchase on each side of a very symmetric 3-3 1/2cm core.The rep did not get a view of the tibia; however, a small cone was used.No distal or proximal augments were used and a competitors 11mm insert was used.Patient was last known to be in stable condition following the event.The device is not available for evaluation as hospital retains all retrievals.In a review of the labeling and ifu 700-060-004, it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure.Also, fracture, migration, loosening, subluxation or dislocation of the prosthesis or any of its components, and any of which could require intervention or revision.And may require a second surgical intervention or revision.Upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.
Event or Problem Description
As reported, 20 years postop the initial implant (bilateral knees), this (b)(6) y/o female patient had a right poly/patella revision.The reason was not reported.The insert was removed, and the femur was removed with 15-20 moderate taps with a light mallet.The tibia had to be removed with revision saw blade and a moderate amount of work.The rep asked to be allowed to take pictures of the retrievals and surgeon agreed.No pictures of the patient¿s bone were allowed.The femur after being prepped for implants was excellent for a 20-year-old primary knee.The rep estimated there was 2cm of purchase on each side of a very symmetric 3-3 1/2cm core.The rep did not get a view of the tibia; however, a small cone was used.No distal or proximal augments were used and a competitors 11mm insert was used.Patient was last known to be in stable condition following the event.The device is not available for evaluation as hospital retains all retrievals.

• Brand Name: PS CEMENTED FEMORAL SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11436314
• Report Number: 1038671-2021-00095
• Device Sequence Number: 3763021
• Product Code: JWH
• UDI-Device Identifier: 10885862047588
• UDI-Public: 10885862047588
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS CEMENTED FEMORAL SZ 3
• Device Catalogue Number: 204-01-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 78 YR
• Patient Weight: 113