MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/54; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Host-Tissue Reaction (1297); Erosion (1750); Pain (1994); Loss of Range of Motion (2032); Reaction (2414)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 15-105044, m2a tpr hi carbon 41/32mm lnr, 912570.X11-180312, bi-metric/x por nc lat 12x140, 774930.11-163688, 32mm m2a hi carbon hd std nk, 767120.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 04296, 0001825034 - 2018 - 04298.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.

Event Description

It was reported that the patient underwent revision surgery approximately 9 years post initial surgery due to pain, limited range of motion, metallosis, pseudotumor and bone erosion.During the surgery it was found that anterior capsule had significant metallosis reaction and staining in the tissue.Radical resection removing the entire anterior and as much of the inferior and superior capsule.There was significant metallosis reaction around the acetabular implant with significant softening and bone loss.

Manufacturer Narrative

It was determined this device did not cause or contribute to the reported event.Please void this submission.

Event Description

It was determined this device did not cause or contribute to the reported event.Please void this submission.

• Brand Name: M2A-T UNIV 2-HOLE SHL SZ 41/54
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8809894
• MDR Text Key: 151704050
• Report Number: 0001825034-2018-04297
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 15-103684
• Device Lot Number: 801490
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention