MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-21-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 75 y/o female patient had a partial revision 6 years post op initial tka.The patient was suffering, was presenting laxity & instability.Synovectomy & lavage were performed.The pe retrieved appeared to be badly damaged for both tibial insert & patella.Surgeon replaced both insert & patella, switching from 9mm to 11mm.No further information provided.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): (b)(6), 200-02-29 - rotule 3 plots diam 29 6.1mm optetrak, (b)(6), 204-32-08 - tige extension diam 12 lg 80, (b)(6), 204-34-08 - tige extension diam 14 lg 80, (b)(6), 204-62-05 - 1/2 cale tibiale ep 5 t.2, (b)(6), 208-01-01 - femur optetrak cimente cc t.1, (b)(6), 208-04-23 - embase tibiale cimentee decalee alpha, (b)(6), 208-04-70 - vis p/platine decalee aa, (b)(6), 208-06-01 - cale femorale distale ep 10 t.1, (b)(6), 208-09-02 - bague femorale 2 degres.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of instability, which led to prosthesis wear.
Additional Manufacturer Narrative
*the following sections have corrected information: (h6) health effect - clinical code, medical device problem.
Additional Manufacturer Narrative
*the following sections have corrected information: (h6) type of investigation, investigation findings, investigation conclusion.

• Brand Name: CC TIBIAL INSERT SZ 1, 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 (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17912967
• Report Number: 1038671-2023-02502
• Device Sequence Number: 7526035
• Product Code: JWH
• UDI-Device Identifier: 10885862054081
• UDI-Public: 10885862054081
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/08/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2020
• Device Catalogue Number: 208-21-09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 02/19/2024; 08/22/2024; 10/18/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 03/04/2024; 09/16/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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.
• Patient Age: 75 YR
• Patient Sex: Female