MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	200-23-11
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/17/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification that an 85 yo female patient, had an initial right knee implanted on (b)(6) 2009, and underwent a revision procedure on (b)(6) 2014, approximately 5 years post op for reasons unknown.No additional information.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 200-02-29 - three peg patella 29mm, (b)(4), 200-04-32 - cemented finned tib.Tra sz 3f/2t, (b)(4), 203-96-01 - (11-2222) saw blade new stryk (.050), (b)(4), 230-03-03 - optetrak asy,cr cemented femoral, sz 3, (b)(4), correction/removal number: z-0019-2022.
Additional Manufacturer Narrative
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, insufficient information.H7: z-0019-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d8, f6, f9 (remove erroneous entries from initial report), g2, h6: clinical code, health effect-impact code, component code, investigation findings.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ3, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15534100
• Report Number: 1038671-2022-01219
• Device Sequence Number: 5285929
• Product Code: JWH
• UDI-Device Identifier: 10885862040251
• UDI-Public: 10885862040251
• 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: 2009
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 10/08/2016
• Device Model Number: 200-23-11
• Device Catalogue Number: 200-23-11
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/30/2022; 03/02/2026
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 10/13/2022; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2008
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female