MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-3; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Adhesion(s) (1695); Metal Related Pathology (4530)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number:139266 lot number:961790 brand name: m2a magnum tpr insrt.Catalog number:157456 lot number: 814560 brand name: m2a magnum head.Catalog number:us157862 lot number:315260 brand name: m2a-magnum pf cup.Catalog number:192411 lot number:219480 brand name: echo por fmrl red nc.Multiple reports were submitted along with this report : 0001825034-2022-00598 and 0001825034-2022-00599.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was revised due to elevated metal ions and adverse local tissue reaction approximately 9 years post implantation.During the revision there was no significant metal debris or staining, minimal tissue necrosis, and weakened posterior capsule.The head and taper adapter were exchanged without complication's.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Initial report should be voided.

• Brand Name: M2A-MAGNUM 52-60MM TPR INSRT-3
• 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: 13860789
• MDR Text Key: 287686753
• Report Number: 0001825034-2022-00598
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 139266
• Device Lot Number: 961790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male