MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 4, 11MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526); Implant Pain (4561); Insufficient Information (4580); Joint effusion (4849)
Date of Event	04/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient had a revision for an unknown reason.This is no pe liner issue due to non-conforming evoh bags.No incident reported to exactech (b)(4), no materiovigilance known by exactech corp or exactech (b)(4).No additional information available.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, patient had a revision for an unknown reason.This is no pe liner issue due to non-conforming evoh bags.No incident reported to exactech (b)(4), no materiovigilance known by exactech corp or exactech (b)(4).No additional information available.
Additional Manufacturer Narrative
As reported, patient had a revision for an unknown reason.This is no pe liner issue due to non-conforming evoh bags.No incident reported to exactech france, no materio-vigilance known by exactech corp or exactech france.Upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is patient conditions.
Event or Problem Description
The patient, who is male, was revised for a second time in (b)(6) 2024.Implant material list provided.Stated on exp report."on document from 2015, i can see the insert (b)(6) (b)(4) & checking the pe: it was non evoh, implanted after 5 years." no further details (b)(6) 2024 revision reported under mdr#1038671-2024-04191.
Additional Manufacturer Narrative
D10 - concomitants: (b)(6) 02-010-02-0240 - composant femoral logic sans ciment t4 gauche, (b)(6) 02-012-45-4040 - embase tibiale fit logic cimentee 4f/4t, (b)(6) 200-02-35 - rotule 3 plots diam 35 8.5mm optetrak, h6 - component code, corrected information: h6 - medical device problem code, health effect clincal code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: d8 the following sections were corrected: b2 h6 the revision reported may be due to laxity, instability, pain, and synovitis but cannot be confirmed since the devices were not available for evaluation, and no patient information, images, or radiographs were provided.The patient was originally implanted with a classic optetrak tibial insert and an optetrak logic femoral component.These devices are not intended to be used together, as detailed in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 4, 11MM
• 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: 13172616
• Report Number: 1038671-2022-00007
• Device Sequence Number: 19999650
• Product Code: JWH
• UDI-Device Identifier: 10885862048394
• UDI-Public: 10885862048394
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• 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): 12/20/2024

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: 09/22/2017
• Device Model Number: PS TIBIAL INSERTS SZ 4, 11MM
• Device Catalogue Number: 204-24-11
• 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: 12/08/2021
• Supplement Date Received by Manufacturer: 06/20/2022; 10/28/2024; 12/10/2024
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 07/22/2022; 11/07/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2009
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention; Hospitalization
• Patient Sex: Male