MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-012-44-1009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-010-01-0310 - logic femoral ps cem right sz 1, 4046922; 02-012-45-1010 - lgc tibial fit tray cem sz 1f / 1t, 4059402; 200-02-32 - three peg patella 32mm, 4021542; a10012 - gps implant kit v2, 06038015015h7.Recall number: z-0021-2022.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2016.Beginning about one year post-op the patient began to experience numbness in her right knee.In (b)(6) of 2018 she began experiencing dull pain, swelling, locking/catching, and stiffness.Attempts to treat her symptoms with heat/ice, elevation, and nsaids were ineffective.The implanting surgeon suspected femoral loosening due to early polythylene wear.The patient was revised on (b)(6) 2019.Upon explantation of the devices, the surgeon observed significant granulation tissue due to polyethylene wear, and noted "excessive wear in the medial and lateral components when compared to normal wear." the femoral component was "completely loose" and was removed without effort.Upon information and belief, the polyethylene insert was defective, leading to early aseptic loosening.
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; however, it may have been the result of malalignment between the femoral and tibial components, third body wear, patient-related conditions, or any combination of these possibilities, which led to prosthesis wear.
Additional Manufacturer Narrative
H11.Correction - it has been determined by engineering that this is a duplicate of case, as verified by sn (b)(6), cat # 02-012-44-1009.This case will be closed, and all new information will be reported in mfr# 1038671-2019-00442.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM
• 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15590330
• Report Number: 1038671-2022-01301
• Device Sequence Number: 7170171
• Product Code: JWH
• UDI-Device Identifier: 10885862173393
• UDI-Public: 10885862173393
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2024

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: 10/25/2020
• Device Model Number: 02-012-44-1009
• Device Catalogue Number: 02-012-44-1009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 04/18/2024
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/09/2022; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2012
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female