MAUDE Adverse Event Report: EXACTECH, INC. ADVANCED PATELLA 35MM 3 PEG IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-07-35
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Report 2 of 2: it was reported that the patient underwent an initial total shoulder replacement on the left side.Subsequently, 3 months post-operative, the patient experienced a dislocation with progressive lateral patellar subluxation and was prescribed a mcl brace and physical therapy.It was later reported that the patient is still experiencing the dislocation and subluxation.As a result, approximately 1 year after initial replacement, the patient underwent open lateral retinacular release surgery.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
Concomitant device(s): 02-020-11-0240 - truliant ps cem fem ps cem left sz 4: (b)(6); 02-022-35-4015 - truliant tib imp ps insert sz 4 15mm: (b)(6); 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t: (b)(6); 200-07-35 - advanced patella 35mm 3 peg implant: (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6); 201-78-82 - collar fixation pin 2pk 40mm, quick release: (b)(6); 201-78-25 - small headed sharp pin, 1 1/8" 4 pack: (b)(6).The reason for the patella subluxation and subsequent lateral retinacular release reported cannot be conclusively determined; however, it may be related to component positioning, surgical technique, and/or patient-related factors.The reported event could not be confirmed as the devices remain implanted, and relevant patient information, images, or radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ADVANCED PATELLA 35MM 3 PEG IMPLANT
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23704096
• Report Number: 1038671-2025-03472
• Device Sequence Number: 10691610
• Product Code: JWH
• UDI-Device Identifier: 10885862314291
• UDI-Public: 10885862314291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: 11/28/2022
• Device Catalogue Number: 200-07-35
• 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: 12/04/2023
• Initial Report FDA Received Date: 12/03/2025
• Date Device Manufactured: 11/30/2017
• 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
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: Black Or African American