MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 4, 9MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	200-74-09
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation: d10.Concomitants: (b)(6) 13a2101 - cemex system fast genta 70g, (b)(6) 200-02-38 - three peg patella 38mm, (b)(6) 200-04-44 - cemented finned tib.Tra sz 4f/4t, (b)(6) 200-74-09 - cr tibial insert sz 4, 9mm, slope ++, (b)(6) 201-78-14 - holding pin headless sharp point long 4pk, (b)(6) 201-78-15 - holding pin mini sharp point 4 pk, (b)(6) 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19, (b)(6) 230-03-04 - optetrak asy,cr cemented femoral, sz 4, (b)(6) asa0030 - sterile disposable containers.
Event or Problem Description
As reported via legal documentation, a patient had right knee replacement surgery on (b)(6) 2010.They underwent right knee revision surgery on (b)(6) 2020, approximately 9 years 8 months post primary procedure.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Correction: upon investigation this has been discovered to be a duplicate case, all new/additional information will be appropriately processed and reported under mfr# 1038671-2020-00290.

• Brand Name: CR TIBIAL INSERT SZ 4, 9MM, SLOPE ++
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 17361472
• Report Number: 1038671-2023-01716
• Device Sequence Number: 12284707
• Product Code: JWH
• UDI-Device Identifier: 10885862041296
• UDI-Public: 10885862041296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K082022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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
• Device Expiration Date: 12/01/2013
• Device Model Number: 200-74-09
• Device Catalogue Number: 200-74-09
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown