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 Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Legal case - usa (master case.(b)(4).Case no.(b)(4).Patient id: (b)(6).It was reported that approximately 119 months after a right knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, severe pain, swelling, and instability, tissue damage, osteolysis, permanent bone loss, and other injuries.No further issues or complications were reported.No additional information is available.(b)(6) 02-012-48-3011 logic cr tib insert slope+, sz 3, 11mm.Serial number: (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Udi: (b)(4).510k: k111400.Concomitant products: (b)(6) - 02-010-03-0330 - logic cr femoral cem, right, sz 3, (b)(6) - 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6) - 200-03-32 - one peg patella 32mm, (b)(6) - 201-78-25 - small headed sharp pin, 1 1/8" 4 pack, (b)(6) - 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.Original description summary: legal case - usa, patient id: (b)(6).This patient is verified for right knee on dr.(b)(6) list.He had right knee revision on (b)(6) 2023 with dr.(b)(6).Possible match found on the knee list for dr.(b)(6).Patient id: (b)(6), surgery/invoice date: on (b)(6) 2013, date of insert manufacture: 2011-08-02, shelf life at time of implementation: 1 - 2, item number and full corporate description: 02-012-48-3011 - logic cr tib insert slope+, sz 3, 11mm, serial number: (b)(6), insert thickness: 11.No device return anticipated due to this being a legal case.Ebi initial surgery attached.Historical record & smartsolve searched for sn/patient name with no results.No further information.(b)(6), 02-012-48-3011 logic cr tib insert slope+, sz 3, 11mm.Serial number: (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.Udi: (b)(4), 510k: k111400.Concomitant products: (b)(6) - 02-010-03-0330 - logic cr femoral cem, right, sz 3, (b)(6) - 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t, (b)(6) - 200-03-32 - one peg patella 32mm, (b)(6) - 201-78-25 - small headed sharp pin, 1 1/8" 4 pack, (b)(6) - 203-96-42 - 11-4132 stryker sys 6 90x13/21x1.19.
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 approximately 119 months after a right knee replacement procedure, the patient underwent a revision procedure to address polyethylene wear, severe pain, swelling, and instability, tissue damage, osteolysis, permanent bone loss, and other injuries.No further issues or complications were reported.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: 21223328
• Report Number: 1038671-2025-00377
• Device Sequence Number: 8795606
• Product Code: JWH
• UDI-Device Identifier: 10885862039651
• UDI-Public: 10885862039651
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2014
• 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?: Yes
• Distributor Facility Aware Date: 12/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 61 YR
• Patient Sex: Female