MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-13
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6) 200-04-22 - (disc) cemented finned t ib.Tra sz 2f/2t.(b)(6) 234-02-02 - (disc) optetrak asy,ps c emented femoral, sz 2.(b)(6) 21-0901-19l-v1 - hall lpi90x13/21x1.19 nueva (v193-119-90).(b)(6) 21-0901-19y-v1 - stryker lpi s7/6/5/4 h.Sierra 90*13/21*1,19.H3: the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that this patient's left knee was revised approximately 8 years 6 months post initial operation.Patient was experiencing premature wear of the polyethylene with mechanical loosening of the implant secondary to massive osteolysis.Patient was revised to a competitor's device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6, h11.The following sections were corrected: h6.H11: the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was performed, and no discrepancies were found.A definitive root cause was unable to be determined; however, was likely due to the reported loosening, prosthesis wear, or due to the inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral and/or tibial component to the respective bone, may have lead to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, excessive posterior slope, third body wear, patient-related conditions, instability, or any combination of these possibilities.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 2, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22411232
• Report Number: 1038671-2025-02426
• Device Sequence Number: 21251017
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 07/15/2018
• Device Catalogue Number: 204-22-13
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2010
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female