MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM INSERT; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: us157852 ¿ m2a magnum cup ¿ 959530; 157446 ¿ m2a magnum head ¿ 784260; 13-103206 ¿ taperloc stem ¿ 187410.Customer has indicated that the product will not be returned to zimmer biomet as the product location is 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 - 2020 - 02036.

Event Description

It was reported that patient underwent a left hip revision approximately 10 years post implantation.During the procedure, the femoral head was found to be cold-welded to the stem and required an extended trochanteric osteotomy in order to be explanted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting that a bony tamp and a mallet placed at the base of the head was used in an attempt to remove the implant.Removal was unsuccessful as the taper was found to be cold-welded to the stem.An eto was performed in order to remove the stem.Eto was secured with a trochanteric claw.Shr was reviewed and no discrepancies were found.The root cause is 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.

Event Description

No additional event information to report at this time.

• Brand Name: M2A MAGNUM INSERT
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10066222
• MDR Text Key: 193937555
• Report Number: 0001825034-2020-02035
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 057990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention