MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	PS TIBIAL INSERTS SZ 5, 11MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: ps tibi al inserts sz 5, 11mm (cat#: 204-25-11/serial#: (b)(4)).As reported, 16 years postop the initial (b)(6) y/o male patient presented recently with a left knee infection.A i&d was performed with an extensive washout.The joint was stable after debridement, so the same size poly was inserted.Due to the swelling of the joint, minimal incision, and subluxation, it was difficult to insert the final implant.One poly was wasted due to deformity while impacting.There was a 5-15 minute delay with no adverse events as a result of the surgical delay/prolongation replacing the insert.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.Upon review, there is no indication of manufacturing or design issues.The most likely cause of the reported event appears to be the results of the patient conditions, which caused the infection.
Event or Problem Description
As reported, 16 years postop the initial (b)(6) y/o male patient presented recently with a left knee infection.A i&d was performed with an extensive washout.The joint was stable after debridement, so the same size poly was inserted.Due to the swelling of the joint, minimal incision, and subluxation, it was difficult to insert the final implant.One poly was wasted due to deformity while impacting.There was a 5-15 minute delay with no adverse events as a result of the surgical delay/prolongation replacing the insert.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.

• Brand Name: PS TIBIAL INSERTS SZ 5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11611933
• Report Number: 1038671-2021-00151
• Device Sequence Number: 3086347
• Product Code: JWH
• UDI-Device Identifier: 10885862048479
• UDI-Public: 10885862048479
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2021

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 Model Number: PS TIBIAL INSERTS SZ 5, 11MM
• Device Catalogue Number: 204-25-11
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 74 YR
• Patient Weight: 86