MAUDE Adverse Event Report: EXACTECH, INC. UNI ALL POL TIB COMP LT MEDIAL 8MM SZ 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	252-12-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6b: explanted in 2018.Specific date unknown.D10 concomitant devices: (b)(6), 250-01-03 - uni femoral component sz 3.(b)(6), 201-78-81 - 3" trocar, mod.Hex 2pk.The product associated with the reported event is within the scope of recall z-0020-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that this patient's knee was revised in 2018 approximately 4 years post initial operation, (b)(6) 2014.Patient stated they underwent a knee replacement surgery on their left knee, which failed, requiring total knee restoration surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5 if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that this patient's knee was revised approximately 4 years post initial operation.Patient stated they underwent a knee replacement surgery on their left knee, which failed, requiring total knee restoration surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4, d10, h4 and.H6 - type of investigation, investigations findings and investigation conclusions.D1, d4 and h4: unknown.D10: 1778473 252-12-03 - uni all pol tib comp lt medial 8mm sz 3.3535120 250-01-03 - uni femoral component sz 3.3633350 201-78-81 - 3" trocar, mod.Hex 2pk.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.

• Brand Name: UNI ALL POL TIB COMP LT MEDIAL 8MM SZ 3
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 21314914
• Report Number: 1038671-2025-00672
• Device Sequence Number: 8848938
• Product Code: HRY
• UDI-Device Identifier: 10885862065773
• UDI-Public: 10885862065773
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2015
• Device Catalogue Number: 252-12-03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 03/13/2025; 04/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/13/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female