MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-24-13
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
As reported by the legal department, a patients had osteoarthritis of l knee with severe medial compartment degenerative changes; status post segmental femur fracture with significant malalignment changes required left knee replacement.Approximately 10 years post op the initial left knee, this 53 y/o male patient was revised due to the replacement separating.Patient was unable to to revised right away due to medical issues.It is stated that as a result, the patient had to deal with a lot of pain and was limited in their ability to walk or stand.In the last few years before the revised surgery, he had to use a cane and, at times, required additional assistance in personal care.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: g3/g4.The following sections were corrected: a2, b3, d1, d4, d6b, d10: 204-01-04 ps cemented femoral sz 4, 204-04-44 trapezoid tibial tray sz 4f/4t, 200-02-35 three peg patella 35mm, e1, e2/e3, g2.H6: health effect - clinical code, component code, type of investigation, and investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported by the legal department, a patient had osteoarthritis of l knee with severe medial compartment degenerative changes; status post segmental femur fracture with significant malalignment changes required left knee replacement.Approximately 125 months post op the initial left knee, this 63 y/o male patient was revised due to the replacement separating.Patient was unable to be revised right away due to medical issues.It is stated that as a result, the patient had to deal with a lot of pain and was limited in their ability to walk or stand.In the last few years before the revised surgery, he had to use a cane and, at times, required additional assistance in personal care.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, e.Pma 510k cannot be determined; device is unknown.Serial number, expiration and manufactured dates unknown.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15796354
• Report Number: 1038671-2022-01464
• Device Sequence Number: 4649271
• Product Code: JWH
• UDI-Device Identifier: 10885862048400
• UDI-Public: 10885862048400
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 204-24-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 04/08/2025; 05/28/2025
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 04/30/2025; 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male