• 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-MAGNUM MOD HD SZ 46MM 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-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Unstable (1667)
Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Reaction (2414)
Event Date 04/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: biomet m2a magnum pf cup us157852 lot 199420. Biomet mallory head pf femoral 11-104111, lot 660430. Biomet m2a magnum taper adapter, 139258, lot 021590. The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01416, 0001825034-2020-01417.
 
Event Description
It was reported a patient had an initial right. Subsequently, the patient was revised approximately 13 years later due to pain, instability, metallosis, loosening, tissue damage, elevated metal ion levels, osteolysis, and bone erosion. Medical records received and reviewed indicate the following: gross loosening of the acetabular cup with partial disruption of the abductor mechanism; metallosis identified; the patient presented with progressing pain and instability; the abductor had partially detached from the anterior third at the greater trochanter; some osteolysis noted around the proximal femur-stem well fixed. During the revision, devices were implanted to provide greater stability. The abductors were also repaired prior to closure. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameM2A-MAGNUM MOD HD SZ 46MM
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 Key9920807
MDR Text Key188482406
Report Number0001825034-2020-01415
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2016
Device Model NumberN/A
Device Catalogue Number157446
Device Lot Number342860
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 Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2006
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: 04/03/2020 Patient Sequence Number: 1
-
-