MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant product: p/n 139252 m2a-magnum 42-50mm tpr insrt-6 l/n 470670.P/n 103206 taperloc por fmrl 12.5x145 l/n 500550.P/n us157856 m2a-magnum pf cup 56odx50id l/n 488400.The devices were not returned for evaluation to the manufacturer at this time.No further information has been made available.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a hip revision procedure, the femoral head was found cold welded onto the trunnion.After multiple attempts to disimpact the head, a metal cutting burr was used to remove the head.The well-fixed femoral stem remained implanted.This resulted in a one hour delay in procedure.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of revision operative report.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.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: M2A MAGNUM TAPER
• 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: 6848573
• MDR Text Key: 85134085
• Report Number: 0001825034-2017-06993
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 470670
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2006
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 109