MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50M TPR INSRT +3; PROSTHESIS, HIP

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Scar Tissue (2060)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us157854 m2a-magnum pf cup 54odx48id 302240, 157448 m2a-magnum mod hd sz 48mm 48mm 339660, 192012 echo por fmrl nc 12x140mm 267000.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2020-00863 stem.

Event Description

Patient¿s legal counsel reported patient underwent right total hip arthroplasty.The patient was revised seven years later due to cup migration, altr, and corrosion.During the surgery, it was discovered that the insert and stem had cold welded together and would not separate.While trying to remove the femoral components, the femur was fractured.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected   medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues, cold-welded femoral head, unable to remove the stem as reported.The investigation could not verify or identify any evidence of product contribution to the reported problem.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

It was reported by patient's legal counsel initial right total hip arthroplasty, subsequently revised on 7 years post implantation due to acetabular fracture and metal on metal.During the revision the acetabular component was protruding into the pelvis, the femoral head was cold-welded, and scar revision to previous incision.An extended trochanteric osteotomy was performed to remove the head and stem.All components were replaced with competitor product.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A-MAGNUM 42-50M TPR INSRT +3
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9746358
• MDR Text Key: 188352593
• Report Number: 0001825034-2020-00862
• Device Sequence Number: 1
• Product Code: KWA
• 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,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2018
• Device Model Number: N/A
• Device Catalogue Number: 139258
• Device Lot Number: 880580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 05/15/2020; 11/02/2021
• Supplement Dates FDA Received: 05/22/2020; 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Weight: 134