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

Model Number	CR TIBIAL INSERT SZ 2, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 204-04-23 - trapezoid tibial tray sz 1f/3t, 2f/3t sn: (b)(4), 204-34-04 - fluted stem extension 40l x 14 mm sn: (b)(4), 204-70-00 - tibial stem ext.Screw sn: (b)(4), 230-03-02 - optetrak asy,cr cemented femoral, sz 2, sn: (b)(4), 200-02-35 - three peg patella 35 mm sn: (b)(4), 620-00-02 - platelet rich plasma kit with spray tips sn: (b)(4), 620-11-02 - accelerate conc.Sys rep by 620-12-02 sn: (b)(4).
Event or Problem Description
As reported by legal, that this patient's right knee was implanted (b)(6) 2009.Revision date: (b)(6) 2015; reason for the revision was not reported.No additional information provided.
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
G3/g4: date was accidentally left off on follow-up #1.
Additional Manufacturer Narrative
Manufacturer narrative updated: the reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear/failure could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.

• Brand Name: CR TIBIAL INSERT SZ 2, 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: 15334331
• Report Number: 1038671-2022-00990
• Device Sequence Number: 6478343
• 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: 2009
• Device Explanted Year: 2015
• 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): 10/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2017
• Device Model Number: CR TIBIAL INSERT SZ 2, 11MM
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 09/07/2022; 10/15/2024
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 09/27/2022; 10/06/2022; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2009
• 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
• Patient Sex: Female