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 Codes	Failure of Implant (1924); Subluxation (4525)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 02-020-11-0240 - truliant ps cem fem ps cem left sz 4: (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).201-78-25 - small headed sharp pin, 1 1/8" 4 pack: (b)(6).201-78-82 - collar fixation pin 2pk 40mm, quick release: (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).
Event or Problem Description
Study: (b)(6) clinical study.Subject: (b)(6).As reported by the (b)(6) clinical study, the patient had an initial left tka on (b)(6) 2018 and presented on (b)(6) 2018 with dislocation - progressive lateral patellar subluxation reported about 3 months ago post-op and continued despite physical therapy and bracing.Open lateral retinacular release was performed on (b)(6) 2018 for patellar subluxation left total knee.The case report form indicates that this event is unknown to be related to the device and/or to the procedure.Mcl brace, pt and open lateral retinacular release surgery (b)(6) 2018.The outcome of this event is resolved on (b)(6) 2018.Height: 69 in.Diagnosis: osteoarthritis.Comorbidities: hypertension, insulin dependent diabetes mellitus, celiac disease, sleep apnea, chronic back pain, gerd, peripheral neuropathy, sss/pacemaker, bph.200-07-35 - advanced patella 35mm 3 peg implant: (b)(6).510k: k160484.Concomitants: 02-022-35-4015 - truliant tib imp ps insert sz 4 15mm: (b)(6).Serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k152170.02-020-11-0240 - truliant ps cem fem ps cem left sz 4: (b)(6).02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t: (b)(6).201-78-25 - small headed sharp pin, 1 1/8" 4 pack: (b)(6).201-78-82 - collar fixation pin 2pk 40mm, quick release: (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).No device return anticipated due to being a clinical trial study.Ebi initial surgery attached.Historical records, smartsolve, and inbox searched for serial numbers and/or clinical trial subject with no results.No further information.
Event or Problem Description
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.As a result, the patient was prescribed a mcl brace and physical therapy.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b5, h6 mdr section codes updated/corrected: b, c, d, e, f, g b3: date is unknown.The reason for the patella subluxation and subsequent bracing and physical therapy 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 ; 3523771140
• MDR Report Key: 18481148
• Report Number: 1038671-2024-00059
• Device Sequence Number: 15066754
• 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: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 H10.
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 111 KG
• Patient Race: Black Or African American