MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A TPR HI CARBON 41/32MM LNR PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices: 103535 ti low profile screw 6. 5x40mm 707940; 103534 ti low profile screw 6. 5x35mm 394800; 15-103684 m2a-t univ 2-hole shl sz 41/54 056120; 103533 ti low profile screw 6. 5x30mm 937120; 15-105044 m2a tpr hi carbon 41/32mm lnr 080230; 11-163688 32mm m2a hi carbon hd std nk 404450; 103206 taperloc por fmrl 12. 5x145 247230. The device will not be returned for analysis, as the surgeon didn't approve for return; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01933; 0001825034-2021- 01935.

Event Description

It was reported a patient underwent a hip arthroplasty approximately 13 years ago. Subsequently, the patient was revised approximately 2 weeks ago as the surgeon claims the patient was experiencing metal reaction related issues. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A TPR HI CARBON 41/32MM LNR
• 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: 12093081
• MDR Text Key: 259202039
• Report Number: 0001825034-2021-01934
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 15-105044
• Device Lot Number: 080230
• 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: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2008
• 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: 06/30/2021 Patient Sequence Number: 1