MAUDE Adverse Event Report: Synthes GmbH 3.5/4.5MM VA PPFX PROX FEMUR PLATE/8HOLES/RIGHT/STERILE; Plate, fixation, bone

Catalog Number	02.221.114S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6) study no: no information provided.Clinical adverse event received for fixation failure (displacement of fixation) with specifically: displacement of screws, displacement of plate, breakage of screw(s) device related: yes procedure related: yes date of event: 29-jun-2026.Date of implant: (b)(6)2025.Date of revision: (b)(6) 2026.Device location: distal femur.Treatment/impact: infection at the time of the periprosthetic plate placement (2025 (b)(6)), resulted in medical or surgical intervention: yes, required in-patient hospitalization or prolongation of existing hospitalization: yes, resulted in a permanent impairment of a body structure or function: yes, 2-stage surgery - osme (which means osteosynthesis material extraction--meaning, removal of the failed plate and screws) + explantation tkr + spacer on (b)(6) 2026, second stage surgery planned for (b)(6) 2026.Depuy synthes products used: catalog number: no information provided.Lot number: no information provided.Component type: plate description: no information provided.Catalog number: no information provided.Lot number: no information provided.Component type: screw description: no information provided.Catalog number: no information provided.Lot number: no information provided.Component type: screw description: no information provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: 3.5/4.5MM VA PPFX PROX FEMUR PLATE/8HOLES/RIGHT/STERILE
• Common Device Name: Plate, fixation, bone
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50412054
• Report Number: 8030965-2026-08399
• Device Sequence Number: 18755762
• Product Code: HRS
• UDI-Device Identifier: 10886982275882
• UDI-Public: (01)10886982275882
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 02.221.114S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 136 LB