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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product location unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03986.

Event Description

It was reported during a hip revision procedure that the taper was cold-welded to the trunnion.During the procedure, multiple attempts were made the disengage the taper from the stem.A metal cutting bur was used to cut the taper.Due to damage from the metal cutting bur the surgeon decided to remove the stem.The entire procedure was over four hours due to the unexpected difficulty in removing the implants.The taper body was removed.A micro-lock stem was implanted.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records provided.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further actions are required.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 ADAPTER
• 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: 6647300
• MDR Text Key: 77773735
• Report Number: 0001825034-2017-03985
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 657460
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2009
• 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
• Treatment: M2A-MAGNUM CUP PN: US157854 LN: 690920; M2A-MAGNUM MODULAR HEAD PN: 157448 LN: 108260; TAPERLOC MICROPLASTY STEM PN: 14-103205 LN: 188800
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR