MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-24-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information and/or investigation results shall be provided within 30 days of receipt.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement on (b)(6) 2009.They subsequently underwent right knee revision surgery on (b)(6) 2023, approximately 13 years 6 months post primary procedure.Revision op report postoperative disgnosis: failed right total knee arthroplasty due to mechanical loosening and catastrophic polyethylene wear resulting in severe osteolysis.The patient tolerated the procedure well, was awoken and was brought to the recovery room in stable condition.There is no other patient demographic or medical history available.Here is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Recall number: z-0019-2022.1038671-2024-04647, 1038671-2024-04649 this follow-up report is being submitted to relay additional and/or corrected information.D10: concomitants: aa1350 1510-s - cemex system fast 70 gm, 1580510 200-02-38 - three peg patella 38mm, 1578514 200-04-44 - cemented finned tib.Tra sz 4f/4t, 98033 203-96-40 - (11-3973) sys 6 90x25x1.27, 85104 203-96-42 - 11-4132 sys 6 90x13/21x1.19, 1347522 234-03-04 - optetrak asy,ps cemented femoral, sz 4, aa1237 asa0030 - sterile disposable containers.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: 1038671-2024-04647, 1038671-2024-04649.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, tibial loosening, and femoral loosening 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 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.

• Brand Name: PS TIBIAL INSERTS SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 18065968
• Report Number: 1038671-2023-02675
• Device Sequence Number: 7665013
• Product Code: JWH
• UDI-Device Identifier: 10885862048387
• UDI-Public: 10885862048387
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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
• Device Expiration Date: 11/14/2016
• Device Catalogue Number: 204-24-09
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2008
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male