MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	200-22-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 2168310 200-02-32 - three peg patella 32mm, 2246099 230-03-02 - optetrak asy,cr cemented femoral, sz 2, 2260478 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.
Event or Problem Description
It was reported that this female patient's right knee was revised 10 years post op due to premature polyethylene wear of the tibial insert.Patient had loose components and osteolysis.Following the revision surgery, plaintiff continues to be limited in her activities of daily living.Despite undergoing revision surgery, plaintiff experiences daily pain and discomfort in her right knee which limits her activities of daily living and impacts her quality of life.No other information available.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.Section h11: *the following sections have corrected information: (b5) describe event or problem: it was reported via legal that this female patient's right knee was revised 10 years post op due to polyethylene wear of the tibial insert; patient had loose components and osteolysis.No other information available.
Event or Problem Description
It was reported via legal that this female patient's right knee was revised 10 years post op due to polyethylene wear of the tibial insert; patient had loose components and osteolysis.No other information available.

• Brand Name: CR TIBIAL INSERT SZ 2, 11MM
• 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; gaiensville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15545512
• Report Number: 1038671-2022-01248
• Device Sequence Number: 5685128
• Product Code: JWH
• UDI-Device Identifier: 10885862040206
• UDI-Public: 10885862040206
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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: 02/11/2016
• Device Model Number: 200-22-11
• Device Catalogue Number: 200-22-11
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2008
• 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: Female