MAUDE Adverse Event Report: BIOMET ORTHOPEDICS G7 ACETABULAR SYSTEM; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint number corresponding to this medwatch is cmp-(b)(4).The device will be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the distal threads broke while cup was being impacted.There was no patient injury and no delay in the procedure as a result of the event.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The referenced inserter was returned and evaluated against the complaint.Visual inspection of the inserter found superficial scratches indicating repeated use.The inserter is in good overall condition outside of the fracture to the threads.The fractured portion was not returned.Dimensional analysis confirmed the hardness to meet the stated print criteria.Sem-analysis indicates thread deformations strongly suggest the cup was likely cross-threaded onto the shaft threads.This cross-threading might have concentrated the repeated impaction forces onto the improperly attached inserter in one localized spot instead of spreading out.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.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: G7 ACETABULAR SYSTEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6493733
• MDR Text Key: 72841681
• Report Number: 0001825034-2017-02533
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK121874
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• 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: 110003452
• Device Lot Number: 428418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1