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

Catalog Number	200-72-11
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this female patient had a revision on her right knee.Reason for the revision was not reported.
Additional Manufacturer Narrative
(device evaluated by mfr) pending evaluation.
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; no reason for revision was given.Section h11: the following sections have corrected information: (b5) as reported by legal that this female patient had a revision on her right knee on (b)(6)2015.Patient had bilateral knee replacement surgery on (b)(6) 2012.Reason for the revision was not reported.No additional information available.
Event or Problem Description
As reported by legal that this female patient had a revision on her right knee on (b)(6)2015.Patient had bilateral knee replacement surgery on (b)(6) 2012.Reason for the revision was not reported.No additional information available.
Additional Manufacturer Narrative
As a result of additional information, fields d1, d4, d10, and h6 have been updated.Added information to d8.D10.Concomitants: 13a2101 - cemex system fast genta 70g sn: (b)(6), 200-03-32 - one peg patella 32mm sn: (b)(6), 200-04-23 - cemented finned tib.Tra sz 2f/3t sn: (b)(6), 200-22-13 - cr tibial insert sz 2, 13mm sn: (b)(6), 232-02-02 - optetrak asy, cr porous femoral, sz 2, left sn: 1882105, 232-03-02 - optetrak asy, cr porous femoral, sz 2, right sn: (b)(6), 620-00-02 - platelet rich plasma kit with spray tips sn: (b)(6), 620-11-02 - accelerate conc.Sys rep by 620-12-02 sn: (b)(6) h3: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the tibial component and the bone which led to aseptic (non-infected) tibial loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, osteolysis, and tibial loosening could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
H10.Additional information - h7 & h9.

• Brand Name: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• 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: michael crader ; 3523771140
• MDR Report Key: 14933644
• Report Number: 1038671-2022-00757
• Device Sequence Number: 12060873
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/22/2024

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: 02/06/2020
• Device Catalogue Number: 200-72-11
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 01/25/2024; 02/22/2024
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/15/2022; 02/02/2024; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2012
• 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