MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MODULAR MICROPLASTY CUP IMPACTOR ¼¿-28 THREAD INSERT; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly.

Event Description

It was reported that the distal portion of the impactor was damaged during surgery.No patient injury or significant delay was reported as a result of the event.No further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Visual inspection of the device shows distal screw tip fractured.The inserter exhibits signs of repeated use over a potential field service lifetime of 7.5 years.Fracture analysis by sem suggest a overload fracture.Part appears to have had a minimal thread engagement at the time of the fracture, which likely concentrated the load on one turn of thread resulting in shearing the threads off.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.

Manufacturer Narrative

Expiration date was filed in error in our previous report and should be voided as this product is not sterile.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: MODULAR MICROPLASTY CUP IMPACTOR ¼¿-28 THREAD INSERT
• 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: 6328763
• MDR Text Key: 67386319
• Report Number: 0001825034-2017-00642
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2018

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: 11/18/2016
• Device Model Number: N/A
• Device Catalogue Number: 31-400605
• Device Lot Number: 106623
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: 03/02/2018; 03/05/2018; 03/06/2018
• Supplement Dates FDA Received: 03/02/2018; 03/06/2018; 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2009
• 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