MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. EXCEPTION STANDARD FEMORAL STEM SIZE 4; PROSTHESIS, HIP

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).This device is not similar to any devices marketed or manufactured by zimmer biomet in the u.S.; nor is it cleared for distribution in the u.S.; however, this report is being filed as a similar packaging issue has been reported for a device cleared in the u.S.

Event Description

During a hip arthroplasty, it was discovered the inner sterile packaging of the stem was not sealed.Another stem was used to complete the procedure without delay.

• Brand Name: EXCEPTION STANDARD FEMORAL STEM SIZE 4
• Type of Device: PROSTHESIS, HIP
• 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: 6265209
• MDR Text Key: 65573613
• Report Number: 3006946279-2017-00018
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PNOT CLEARED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/11/2021
• Device Model Number: N/A
• Device Catalogue Number: PS126004
• Device Lot Number: 0001107354
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2016
• 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