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

Catalog Number PV129GM2

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: event occurred in germany.Product was not returned or pictures were not provided.Visual and dimensional evaluations could not be performed.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The review of the sterilization certificate indicates that the products were sterilized according to the specification.This device is used for treatment.Reported event is not related to a combination of products, therefore, a compatibility review is not applicable.Complaint history identified no other similar event for the reported item and part/lot combination.Reported event is not related to medical condition.Review of medical record is not applicable.Instruction for use has been reviewed and it is stated the following point: implants are supplied sterile and packaged individually in double wrapping.Sterilization is carried out by exposure to a minimum dose of 25 kgy of gamma irradiation.The expiration date is printed on the label.Do not use implants after the expiration date.The root cause of the reported issue is attributed to user error (expired product implanted).A communication to the customer has been done.No further actions have been initiated as a result of the reported event investigation.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.

Event Description

It was reported an implantation of an expired gts stem.On (b)(6), 2022, a total hip endoprosthesis was on the schedule at the erding clinic.The operation has started and when it came to the implantation it was discovered that the implant had expired on (b)(6), 2022.

• Brand Name: GTS VARIZED 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: 14101565
• MDR Text Key: 298691414
• Report Number: 3006946279-2022-00031
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Catalogue Number: PV129GM2
• Device Lot Number: 0001204517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2022
• Initial Date FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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