MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. UNKNOWN GTS FEMORAL STEM STANDARD; HIP PROTHESIS

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem Failure of Implant (1924)

Event Date 02/28/2023

Event Type  Injury  

Event Description

It was reported by the medical writing team that according to the german registry a femoral stem is noted to have a high septic re-revision rate.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source: foreign¿germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product not returned.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices used for treatment.Medical records were not provided.Ifu has been reviewed and stated that the gts implant stem are indicated for primary surgery.The root cause of the reported issue is attributed to use error.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: UNKNOWN GTS FEMORAL STEM STANDARD
• Type of Device: HIP PROTHESIS
• 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: 16672213
• MDR Text Key: 312587127
• Report Number: 0009613350-2023-00152
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: Prefer Not To Disclose