MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM CEMENTLESS S-3; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Catalog Number PS129GM3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Hip Fracture (2349)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.The review of the device manufacturing quality record indicates that 10 products gts standard femoral stem size -3, reference ps129gm3, batch j6284582 were manufactured on 26 june 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that revision surgery was performed post one month of implant surgery as a fractured line was found in the femur during routine x-ray.No additional patient consequences were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information and corrected information.The product was returned and lab analysis was performed.Visual control shows that there is some scratches just below of the top of the piece on each side, but no apparent damaged or defects on the products has been noticed.Dimensionnal control has been performed.Stems has been found conforming to specification.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding revision due to bone fracture: 1 complaint, this one included, has been recorded on gts standard femoral stem size -3, reference ps129gm3, from (b)(6) 2018 to (b)(6) 2020 according to available data, root cause of the event was unable to be determined.A summary of the investigation is to be sent to the complainant conveying zimmer biomet conclusions.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that revision surgery was performed post one month of implant surgery as a fractured line was found in the femur during routine x-ray.No additional patient consequences were reported.

• Brand Name: GTS STANDARD FEMORAL STEM CEMENTLESS S-3
• 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
• MDR Report Key: 9389401
• MDR Text Key: 168434980
• Report Number: 3006946279-2019-00523
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03599870096758
• UDI-Public: (01)03599870096758
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/26/2023
• Device Catalogue Number: PS129GM3
• Device Lot Number: J6284582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention