MAUDE Adverse Event Report: EXACTECH, INC. ONE PEG PATELLA 32MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	ONE PEG PATELLA 32MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Joint effusion (4849)
Date of Event	01/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case-usa.As reported via legal documentation the patient had a right knee replacement on (b)(6) 2013.Approximately 9 years and 6 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2023 diagnosis: failed right patella implant and polyethylene insert polyethylene insert was removed which showed excessive wear.The patella everted, showed extensive wear.The patient was brought to recovery room in stable condition.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.Operative report from revision surgery attached.As directed by qa management: this legal complaint for polyethylene issues occurred in the us.The event did not occur in, nor is it reportable for australia, brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10: concomitants: (b)(6), 02-012-47-3011 - logic cr tib insert std, sz 3, 11mm.(b)(6), 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.(b)(6), 02-010-03-0330 - logic cr femoral cem, right, sz 3.(b)(6), 201-78-25 - small headed sharp pin, 1 1/8" 4 pack.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.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
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2013.Approximately 9 years and 6 months after the initial procedure the patient had a right knee revision on (b)(6) 2023.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: ONE PEG PATELLA 32MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20879571
• Report Number: 1038671-2024-04706
• Device Sequence Number: 20784634
• Product Code: JWH
• UDI-Device Identifier: 10885862039651
• UDI-Public: 10885862039651
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 01/22/2015
• Device Model Number: ONE PEG PATELLA 32MM
• Device Catalogue Number: 200-03-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 03/26/2025
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male