MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-23-11
Medical Device Problem Codes	Crack (1135); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2022-01192 d10: 02-012-45-3040 - (b)(6) - logc tibial fit tray cem sz 3f / 4t , 200-02-38 - (b)(6) - three peg patella 38mm, 201-78-82 - (b)(6) - collar fixation pin 2pk 40mm, quick release, 201-78-88 - (b)(6) - 4" drill bit, mod.Hex 2-pk.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-01192.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening, prosthesis wear, and cracking.Or due to inclusion of the polyethylene in the packaging recall.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.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
It was reported that approximately 70 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, ambulation difficulties, balance problems, discomfort, osteolysis, pain and synovitis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.

• Brand Name: PS TIBIAL INSERTS SZ 3, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21240409
• Report Number: 1038671-2025-00422
• Device Sequence Number: 20970245
• Product Code: JWH
• UDI-Device Identifier: 10885862048318
• UDI-Public: 10885862048318
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2018
• Device Catalogue Number: 204-23-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male