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

Model Number	204-23-11
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: patella - cn: 200-02-35; sn: (b)(4).Tibia plateau - cn: 200-04-33; sn: (b)(4).Femur - cn: 234-02-03; (b)(4).
Event or Problem Description
As reported, the patient had an initial tka in (b)(6) 2018.The patient started to feel pain and discomfort in the knee around (b)(6) 2021 and consulted with his surgeon in (b)(6) 2021 with swelling and limping when walking.The patient underwent complementary exams that indicated loosening of the prosthesis with polyethylene wear and bone lysis in the tibial plateau.The patient was revised with a spacer in late (b)(6) 2022.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of femoral component loosening and wear of the tibial insert.Loosening of the femoral component may have preceded and contributed to wear of the tibial insert and subsequent particle-induced osteolysis or particle-induced osteolysis from instability and wear of the insert may have contributed to component loosening and further damage of the insert.However, the individual contributions of femoral component loosening, prosthesis wear, osteolysis, and infection to the sequence of events cannot be determined as serial radiographs were not available and the device was not received for evaluation.H7: z-0019-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of femoral component loosening and wear of the tibial insert.Loosening of the femoral component may have preceded and contributed to wear of the tibial insert and subsequent particle-induced osteolysis or particle-induced osteolysis from instability and wear of the insert may have contributed to component loosening and further damage of the insert.However, the individual contributions of femoral component loosening, prosthesis wear, osteolysis, and infection to the sequence of events cannot be determined as serial radiographs were not available and the device was not received for evaluation 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 3, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15883327
• Report Number: 1038671-2022-01531
• Device Sequence Number: 17397440
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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 Expiration Date: 09/27/2021
• Device Model Number: 204-23-11
• Device Catalogue Number: 204-23-11
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 07/14/2023; 01/15/2025
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 07/25/2023; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2013
• 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: 67 YR
• Patient Sex: Male