MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FMRL STEM SIZE +4; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Model Number N/A

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/19/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery due to fracture of femoral component, caused by fall trauma.Revision was performed eight (8) years eight (8) months from initial hip arthroplasty.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).D10 - medical devices: regenerex ringloc item#pt104056, lot#814810.Ringloc e1 item#ep043254, lot#2754272.G2 - foreign: the netherlands.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Instructions for use (ifu) f225, has been reviewed and it states in paragraph 7 : factors likely to compromise implant success and device performance are: ¿ significant deformations, congenital dislocation.¿ local bone tumors.¿ ligament instability or serious and untreatable muscle contractures.¿ patient history of infections or repeated falls.Radiographs were provided and reviewed from a radiologist.Two x-rays have been provided : one at 5 years follow up- before fracture, and 1 with the fracture.Patient fell on (b)(6) 2022 at home.There is a moderately displaced periprosthetic fracture of the proximal left femur.The femoral implant is loose and subsided due to the fracture.There is no abnormal radiolucency.Bone quality is osteopenic.Other than the fracture no other abnormalities or concerns are noted.The root cause of the reported issue is attributed to the patient fall and the osteopenia (bone quality).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.

Event Description

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

• Brand Name: GTS STANDARD FMRL STEM SIZE +4
• Type of Device: PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17133522
• MDR Text Key: 317208680
• Report Number: 3006946279-2023-00057
• Device Sequence Number: 1
• Product Code: OQI
• UDI-Device Identifier: 03599870096826
• UDI-Public: (01)03599870096826(17)161224(10)0000696926
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/24/2016
• Device Model Number: N/A
• Device Catalogue Number: PS129GP4
• Device Lot Number: 0000696926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 72 KG