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

Catalog Number	204-01-04
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Abdominal Pain (1685); Ambulation or Postural Difficulties (2544); Joint locking (2672); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.It was reported a patient underwent an initial right total knee arthroplasty.Subsequently, approximately eleven (11) years later, the patient experienced popping, locking up, pain swelling, instability and an inability to bear weight on the right knee.As a result, the patient underwent a right knee revision procedure.A revision operative report was provided.Operative findings noted the polyethylene tibial component has fractured and had delamination of the bearing surface.There was no evidence of infection.The femoral was removed without bone loss.The patient tolerated the procedure well and arrived in the recovery room in stable condition.Additionally, it was reported via legal documentation the patient continues to experience prolonged and lasting pain and suffering.No additional information is available.
Additional Manufacturer Narrative
D10: 204-14-11 - ps all poly tibial sz 4, 11mm, 0423469.200-02-35 - three peg patella 35mm, 0922329.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2018-00513, 1038671-2022-01557.The complaint device was evaluated, and the reported event was confirmed.The evaluation identified burnishing that appears consistent with using an osteotome to remove the femoral component during the revision surgery.Due to the fractured spine of the tibial polyethylene component, it is possible that the femoral component became unstable, resulting in femoral loosening.A review of manufacturing data was performed and no discrepancies relevant to the reported event were found.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of excessive loading contact between the ps tibial insert spine and the anterior surface of the femoral cam, which led to ultimate fracture of the tibial insert spine.Due to the fractured spine, it is possible that the femoral component became unstable, resulting in femoral loosening and additional damage to the polyethylene.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS CEMENTED FEMORAL SZ 4
• 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: ashley harris ; 2320 nw 66th ct; gainesville, FL
• MDR Report Key: 25094236
• Report Number: 1038671-2026-00542
• Device Sequence Number: 5031092
• Product Code: JWH
• UDI-Device Identifier: 10885862047595
• UDI-Public: 10885862047595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 06/11/2011
• Device Catalogue Number: 204-01-04
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 05/06/2026
• Date Device Manufactured: 06/12/2006
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male