MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 48MM PROSTHETIC, HIP

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Host-Tissue Reaction (1297); Ossification (1428); Bacterial Infection (1735); Cyst(s) (1800); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Osteolysis (2377); Reaction (2414)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: unk cup, pn unknown, ln unknown, unk taper, pn unknown, ln unknown, unk stem, pn unknown, ln unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05778, 0001825034-2019-05780, 0001825034-2019-05781. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by patients¿ legal counsel that the patient underwent a left hip revision procedure approximately 11 years post-implantation due to metallosis, infection and sepsis, necrosis and tissue damage. Attempts were made to obtain additional information; however, none was available.

• Brand Name: M2A-MAGNUM MOD HD SZ 48MM
• Type of Device: PROSTHETIC, 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: 9526839
• MDR Text Key: 174259288
• Report Number: 0001825034-2019-05779
• 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: other

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 157448
• Device Lot Number: 458780
• 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: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2006
• 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 Treatment Data

Date Received: 12/27/2019 Patient Sequence Number: 1