MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TAPER ADAPTOR; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: item #: us157850, item name: m2a shell, lot #: 022410, item #: 157444, item name: m2a magnum head, lot #: 073060, item #: 11-103203, item name: taperloc femoral stem, lot #: 309130.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 02433.

Event Description

It was reported during hip revision that the trunnion was difficult to remove.The stem and trunnion were removed and replaced.Attempts have been made and no additional information is available.

Manufacturer Narrative

Reported event was confirmed by review of the provided revision op notes which indicated there was difficulty removing the taper from the stem.The revision op notes state there was significant metallosis surrounding the greater trochanter and proximal stem with incomplete fracture noted on the thinned greater trochanter.There was a difficulty of removing the trunion and a bone fracture was recognised possibly from the metal reaction.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 ADAPTOR
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7408414
• MDR Text Key: 104736965
• Report Number: 0001825034-2018-02432
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 520360
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• 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: 65 YR