MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 2F/2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CEMENTED FINNED TIB. TRA SZ 2F/2T
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ps tibial inserts sz 2, 13mm (ca# 204-22-13 / (b)(4)); optetrak asy,ps cemented femoral, sz 2 (cat# 234-02-02 / (b)(4)); three peg patella 29mm (cat# 200-02-29 / (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately twelve years post initial left tka, the female patient presented to the surgeon's office with pain in her left knee.The x-rays showed possible wear or varus stress.The tibia bone looks suspect on x-ray.The patient was scheduled for a revision tka possible poly swap.Upon entering the knee joint, removing the poly, and testing/checking the femoral and tibial components, it was found that the tibial component was loose on the bone.The surgeon was able to lift it up off the bone easily with an osteotome.The surgeon removed all of the exacetch implants and completed a total knee revision using competitor's revision knee system.There was no breakage of devices.There was a 30-45 minute surgical delay/prolongation due to the loose implants causing a longer procedure than anticipated of a poly swap but there was no adverse event as a result.The patient was last known to be in stable condition following the revision procedure.The devices are not available for evaluation due to implants were disposed of by the facility.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3 the revision reported was likely the result of a deterioration of the bond between the tibial tray and the bone after being implanted for approximately 12 years, which led to aseptic (non-infected) loosening of the tibial tray and subsequent pain.The possible reported wear may have been due to backside wear and/or subsidence of the insert into the tibial tray likely from a higher stress concentration on the medial side of the implant.Additionally, the patient may have experienced joint laxity on the lateral side which could result in the observed spacing difference on the provided x-ray.However, this cannot be confirmed because the components were not returned for evaluation and images of the underside of the tibial insert were not provided.The most probable root cause associated with the reported event of "loosening - tibial¿ is associated with weakened integration of the device at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.Furthermore, the most probable root caused associated with "prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 2F/2T
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14420944
• Report Number: 1038671-2022-00556
• Device Sequence Number: 17509099
• Product Code: JWH
• UDI-Device Identifier: 10885862039705
• UDI-Public: 10885862039705
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2015
• Device Model Number: CEMENTED FINNED TIB. TRA SZ 2F/2T
• Device Catalogue Number: 200-04-22
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female