• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER BIOMET, INC. M2A-T UNIV 2-HOLE SHL SZ 41/54 PROSTHESIS, HIP Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameM2A-T UNIV 2-HOLE SHL SZ 41/54
Type of DevicePROSTHESIS, 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 Key8809894
MDR Text Key151704050
Report Number0001825034-2018-04297
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
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 Received07/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2017
Device Model NumberN/A
Device Catalogue Number15-103684
Device Lot Number801490
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 Received07/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/31/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/20/2019 Patient Sequence Number: 1
-
-