MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 9MM, SLOPE +; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eleven years post initial tka, patient had a revision to exchange for a new 12mm insert.Device images received confirmed prosthesis wear.Range of motion (rom) and stability was good.Patient last known to be in stable condition.No furthered information available.X-rays/photos received.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6, h7 and h9 have been updated accordingly.(h3) the revision reported may have been the result of malpositioning of the implants; in particular, the overall posterior slope of the tibial insert and tibial tray, which allowed for excessive contact overtime, especially medially, leading to wear of the polyethylene insert.However, this cannot be confirmed as the devices were not available for evaluation.The most probable root cause associated with the reported event of "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
Investigation has been re-opened up receipt of additional information 31-mar-2023.D10.Concomitants: (b)(6), 200-02-32 - three peg patella 32mm.(b)(6), 200-04-22 - cemented finned tib.Tra sz 2f/2t.(b)(6), 201-46-10 - holding pin headless 3" (4 pk).(b)(6), 230-03-02 - optetrak asy,cr cemented femoral, sz 2.D10 and h4 have been corrected to reflect additional information received.
Additional Manufacturer Narrative
The investigation does not require update, the information provided by the legal department did not provide new product or event information there is no other information available.Correction h4- 09-jun-2008.

• Brand Name: CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14838782
• Report Number: 1038671-2022-00725
• Device Sequence Number: 4832638
• Product Code: JWH
• UDI-Device Identifier: 10885862041029
• UDI-Public: 10885862041029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2023

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: 06/05/2013
• Device Model Number: CR TIBIAL INSERT SZ 2, 9MM, SLOPE +
• Device Catalogue Number: 200-62-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 12/05/2022; 06/22/2023
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 12/21/2022; 04/27/2023; 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2008
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown