MAUDE Adverse Event Report: ZIMMER GMBH UNKNOWN NON-CONTACTING BRIDGING PLATE

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: literature- journal article.Comparison of the functional outcomes after treatment of periprosthetic hip fractures with femoral stem loosening: locking plate fixation with or without femoral stem revision.Tristan vialla, dong tran-minh, florian barbotte, alexandre herault ,matthieu ehlinger, xavier ohl, henri favreau, renaud siboni.Https://doi.Org/10.1016/j.Otsr.2022.103300.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

A study reported that one patient, had a total hip arthroplasty and months later, underwent implantation of a locking plate fixation system due to a periprosthetic fracture.Subsequently, had fixation failure with disassembly of the plate and screws.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.The device is used for treatment.  medical records were not provided.  a definitive root cause cannot be determined.   if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN NON-CONTACTING BRIDGING PLATE
• Type of Device: UNKNOWN
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15819919
• MDR Text Key: 303890847
• Report Number: 0009613350-2022-00569
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN NCB PLATE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Sex: Prefer Not To Disclose