MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM; SEE H10

Catalog Number	02-012-44-5013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Deposits (1809); Failure of Implant (1924); Pain (1994)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a legal notification that a patient who underwent a right knee replacement surgery and was implanted with an optetrak device on (b)(6) 2016, has been advised that his knee replacement has failed and is scheduled to undergo revision surgery on (b)(6) 2022.Upon information and belief, the patient requires revision surgery for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability and/or component loosening.The patient experiences daily pain and discomfort in his knee which limits his activities of daily living and impacts his quality of life.There has been no notification if the patient has been revised as of on (b)(6) 2023.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
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal / polymer.H6.Investigation results: the pending revision reported may be due to prosthesis wear leading to osteolysis and loosening of implants.However, the prosthesis wear and contributions from implant positioning, instability, and / or patient-related factors to the sequence of events cannot be confirmed as the devices are not available for evaluation and limited clinical information was available at the time of evaluation.These devices are used for treatment not diagnosis.There is no device information provided.There is no other information available.
Additional Manufacturer Narrative
H10.D10.Concomitants - product information: 4128361 - 02-012-41-5040 - tray tib 5f/4t knee cmnt trpzdlogic hflex ¿ log8857; 4180293 - 02-010-01-0350 - femur 5 knee rt cmnt post stablogic hflex; 4215572 - 200-02-41 - patella 41mm 3 pg sphrcl optetrak ply sterile stryker simplex hv x 2.The revision reported may have been the result of polyethylene wear, instability, and osteolysis.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the explanted devices were not returned for evaluation and radiographs or photographs were not provided.
Additional Manufacturer Narrative
Additional manufacturer narrative- additional information/ b3, b5, d6b, h6.No changes to investigation results.There is no additional information available.
Event or Problem Description
Revision operative report- instability of prosthetic knee ¿there was delamination of the polyethylene but no evidence of prosthesis loosening.¿ ¿the patella was also not removed because it [was] well fixed with no evidence of polyethylene wear.¿ per pathology report, ¿scattered small polyethylene particles and small metallic particles are present within the histiocytic infiltrate and the giant cells.¿ the patient tolerated the procedure well and was transferred to the recovery room in stable condition.There is no additional information available.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 13MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 17346693
• Report Number: 1038671-2023-01702
• Device Sequence Number: 6524598
• Product Code: JWH
• UDI-Device Identifier: 10885862173737
• UDI-Public: 10885862173737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2022
• Device Catalogue Number: 02-012-44-5013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 04/01/2024; 06/06/2024
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 05/06/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• 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-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male