MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM TAPER ADAPTOR FOR 42-50MM MODULAR HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4)., cat# 157948 lot# 1408674 ha m2a-magnum pf cup 48odx42id cat# 21-124311 lot# 247310 m/h ha por lat fmrl 11x160mm mm g2: foreign ¿ australia the customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.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 approximately sixteen years post-implantation due to instability.The head and taper were revised.It was reported that no further information is available.

• Brand Name: M2A MAGNUM TAPER ADAPTOR FOR 42-50MM MODULAR HEAD
• 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: 19204025
• MDR Text Key: 341296825
• Report Number: 0001825034-2024-01093
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 139252
• Device Lot Number: 1458174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATICE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female