MAUDE Adverse Event Report: BIOMET ORTHOPEDICS MIH MOD CUP INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: regen/rnglc+ ltd 56mm sz 24 catalog#: pt-116056 lot#: k070369.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2016-05242.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the shell was implanted and the surgeon could not free the shell inserter from the shell as it was cold welded into the shell.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The cup was able to be freed from the inserter.Visual inspection of the inserter shows signs of wear and tear over a service lifetime of approximately 4 years.The front gear is fractured and has two gears/ teeth missing.The square end of the inserter has some debris on it where it was joined to the cup; once separated, there is some evidence of corrosion in the threads.Sem analysis of the fractured surfaces of the front gear of the inserter indicated the fracture occurred due to brittle overload.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been 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: MIH MOD CUP INSERTER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 6801926
• MDR Text Key: 82981920
• Report Number: 0001825034-2017-06467
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• 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
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-400600
• Device Lot Number: ZB130401
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2013
• 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
• Patient Outcome(s): Other