MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 58ODX52ID PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Pain (1994); Scar Tissue (2060); Blood Loss (2597)

Event Date 02/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). Reported event was confirmed by review of surgical notes. Patient underwent a revision due to significant pain. No infection noted. There was difficulty in breaking the cold weld attachment and separating the head from the trunnion. There was blood loss of 1200 ml without transfusion. Review of the device history records for reported components identified no deviations or anomalies that could contribute to the reported event. A definitive root cause cannot be determined with the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. (b)(4). Concomitant medical products: m2a-magnum taper sleeve # item 139268 lot 585000. Echo por fmrl nc stem # item 192012 lot 061550. M2a-magnum mod hd sz 52mm, item # 157452, lot 814460. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10113, 0001825034-2018-10114.

Event Description

It was reported that the patient underwent revision surgery approximately seven years post initial surgery due to significant pain and failed conservative measures. During the revision, it was noted there was abundant scar tissue requiring excision, and difficulty breaking the cold weld. Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: M2A-MAGNUM PF CUP 58ODX52ID
• 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: 8203016
• MDR Text Key: 131620252
• Report Number: 0001825034-2018-11550
• 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: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/28/2020
• Device Model Number: N/A
• Device Catalogue Number: US157858
• Device Lot Number: 481240
• 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: 03/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2010
• 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: 12/28/2018 Patient Sequence Number: 1