MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 44MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Material Erosion (1214); Separation Failure (2547)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown-unknown taper-unknown; unknown-unknown 50mm magnum cup-unknown; unknown-unknown biomet mallory 8mm lateralized stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01891; 0001825034 - 2022 - 01892.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a right hip revision approximately 11 years post implantation due to pain, elevated cobalt and chromium levels, decreased adls, and limited mobility.During revision, evidence of metallosis was observed as well as failure of a previously repaired abductor muscle.The femoral head was cold-welded to the femoral trunnion, the head was removed with a metal cutting burr and no damage to the trunnion occurred.The acetabular component and femoral stem were left implanted.The procedure was completed without further complication.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.Component code: mechanical (g04) ¿ head.Complaint confirmed via medical records and radiographs that were provided and reviewed by a health care professional.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot 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 information on the reported event.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.One m2a-magnum mod hd sz 44mm item# 157444 lot# 257590 was returned and evaluated.Upon visual inspection there is damage to the lip of the device along with a wear line, scratches, and an indentation on the o.D.The complaint is confirmed via the returned product and lab results from the previous investigation.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause remains unchanged.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 MOD HD SZ 44MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15250619
• MDR Text Key: 298156664
• Report Number: 0001825034-2022-01889
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 157444
• Device Lot Number: 257590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male