MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. GTS STANDARD FEMORAL STEM SIZE +2; PRESS-FIT HIP FEMUR PROSTHESIS, MODULAR

Catalog Number PS129GP2

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).List of associated devices: maxera cup 40mm x 50mm; ref#00-1515-050-40; lot#62207415.Biolox-delta ceramic femoral head; ref#00-8775-040-02; lot#2691418.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 the stem implanted 8 years ago has broken.As reported by the patient, at the time of the event he was running as he did regularly.In addition it was reported that, as a result of the reported event, a medical intervention/revision was performed on (b)(6) 2021.Also, as reported, at the moment it is not possible to have the return ,as communicated the representative of the area that will give feedback as soon as it is possible to have it.It was also reported that there were no injuries reported as a result of the event (no impairment after the intervention) and that no delays in intervention were reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information and corretions.Received x-rays show that the gts stem fractured at the level of the neck.Therefore, the reported event has been confirmed.The product analysis can't be performed as the product was not returned.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the raw material certificate could not be performed as it couldn¿t be retrieved.The review of the instruction for use of the gts stem shows that the biolox-delta ceramic femoral head used is compatible with the stem.However, the maxera cup used with the gts stem is not part of the compatible devices listed in the ifu.In addition, the ifu mentions the following: all patients should be informed that hip arthroplasty is a major operation, and their hopes should not be raised too high.Patients should be warned not to overwork their prosthesis by performing unreasonable activities that could cause shocks, and to monitor their weight.A complaint extract was done regarding medical : revision: 1 complaint (involving 1 product), this one included, has been recorded on gts standard femoral stem size +2, reference ps129gp2, from 01- jan-2018 to 02-nov-2021.1 complaint (involving 1 product), this one included, has been recorded on gts standard femoral stem size +2, reference ps129gp2, batch 0000811445, since ever.According to available data, root cause of the event was unable to be determined.However, there is no evidence that the event is related to the product.A summary of the investigation has been transmitted to the customer.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 the stem implanted 8 years ago has broken.As reported by the patient, at the time of the event he was running as he did regularly.The implant was revised.Also, as reported, at the moment it is not possible to have the return, as communicated the representative of the area that will give feedback as soon as it is possible to have it.

• Brand Name: GTS STANDARD FEMORAL STEM SIZE +2
• 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: 12371153
• MDR Text Key: 268428652
• Report Number: 3006946279-2021-00141
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2018
• Device Catalogue Number: PS129GP2
• Device Lot Number: 0000811445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male