Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 42-50 TPR INSRT STD; 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 42-50 TPR INSRT STD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Reaction (2414); Patient Problem/Medical Problem (2688)
Event Date 10/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03788, 0001825034 - 2020 - 03790, 0001825034 - 2020 - 03791.
 
Event Description
It was reported a patient had an initial left tha.Subsequently, the patient was revised approximately 11 years later due to metallosis, pain, ho, elevated metal ion levels, altr, scar tissue, and tissue damage.The head and the taper adapter were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
Upon reassessment of the reported event, the taper insert was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the taper insert was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
M2A-MAGNUM 42-50 TPR INSRT STD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10683603
MDR Text Key211506858
Report Number0001825034-2020-03789
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number139256
Device Lot Number983060
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/25/2020
Initial Date FDA Received10/15/2020
Supplement Dates Manufacturer Received11/23/2020
Supplement Dates FDA Received11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-