MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. EXCEPTION; EXCEPTION STANDARD STEM TRIAL NECK S456

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that 7 instruments from the same batch broke in one year.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported that 7 instruments from the same batch broke in one year.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated: b4, b5, d10, g4, g7, h1, h2, h3,h6, h10.The device has been returned to the manufacturer.The device analysis showed that 7 products that have been returned.There were 2 products that are totally broken on the bottom of the pieces and a part of the piece is missing.3 products were damaged and twisted on one side on the bottom of the pieces.2 products were not damaged but twisted on the bottom of the piece.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.The review of the raw material certificate shows no non conformity or deviation.1 complaint, this one included, has been recorded on exception standard stem trial neck s456, reference a120s456, batch 1661809040.According to available data, root cause of the event was unable to be determined.A summary of the investigation was sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trend.

Event Description

It was reported that 2 instruments fractured.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay corrected information.The following section has been updated : b4, b5, g4, g7, h1, h2 and h10.The products were returned and lab analysis was performed.1 product is damaged and twisted on one side on the bottom of the pieces.The other one is not damaged but twisted on the bottom of the pieces.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.A complaint extract was done regarding instrument fracture: 1 complaint (involving 2 products), this one included, has been recorded on exception standard stem trial neck s456, reference a120s456, batch 1661809040.Investigation results concluded that the reported event was due to wear and tear from use.A summary of the investigation was sent to the complainant.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.

• Brand Name: EXCEPTION
• Type of Device: EXCEPTION STANDARD STEM TRIAL NECK S456
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9589983
• MDR Text Key: 196068023
• Report Number: 3006946279-2020-00008
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: A120S456
• Device Lot Number: 1661809040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1