MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM 52 TAPER ADAPTER PROSTHESIS HIP

Device Problem Corroded (1131)

Patient Problems Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 010000703/ m2a magnum cup 58 mm /lot # unknown. Item# unknown / m2a magnum 52 mm modular head / lot # unknown. Item # unknown / microbalance femoral stem /lot # unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00736, 0001825034 -2021 -00745, and 0001825034 - 2021 -02968.

Event Description

It was reported patient underwent left hip revision surgery approximately 12 years post implantation due to allegations of pain, elevated levels of cobalt and chromium, tissue deconstruction, bone deconstruction, and metal wear. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A MAGNUM 52 TAPER ADAPTER
• 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: 12719165
• MDR Text Key: 279011986
• Report Number: 0001825034-2021-02969
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/29/2021 Patient Sequence Number: 1