MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 5, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported, the patient had a left knee implanted on (b)(6) 2016.The patient was revised on (b)(6) 2022 due to unknown reasons.No other information provided.
Event or Problem Description
As reported by legal notification, the male patient had an initial left tka on (b)(6) 2016.The patient had a left knee revision on (b)(6) 2016.The patient had a second left knee revision surgery on (b)(6) 2022 due to accelerated and preventable wear of the optetrak polyethylene tibial insert.No other patient information/medical history reported.
Additional Manufacturer Narrative
Correction/additional information: b4, h6.
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 patient has bilateral knee replacements, this suggests joint maladies.The cause of the subsequent revision cannot be conclusively determined, insufficient information.H7: z-0019-2022.Related to 1038671-2022-01001.
Additional Manufacturer Narrative
H3: the revision reported may have been due to prosthesis wear as reported.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.A contributing factor to the reported wear and/or revision may have been the result of being packaged in a non-conforming bag for more than 5 years.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: c, d, e, g.The revision reported may have been due to prosthesis wear as reported.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.A contributing factor to the reported wear and/or revision may have been the result of being packaged in a non-conforming bag for more than 5 years.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 5, 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15335254
• Report Number: 1038671-2022-01002
• Device Sequence Number: 6439194
• Product Code: JWH
• UDI-Device Identifier: 10885862048462
• UDI-Public: 10885862048462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 11/17/2018
• Device Model Number: PS TIBIAL INSERTS SZ 5, 9MM
• Device Catalogue Number: 204-25-09
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 02/28/2023; 08/31/2023; 01/07/2025
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/13/2022; 03/24/2023; 09/14/2023; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2010
• 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: Male