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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSR +3 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSR +3 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 05/06/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: 192515, echo por fem red lat nc 15x155, lot 428220, 157460, m2a-magnum mod hd sz 60mm, lot 899620, abx-us157866, 66od x 60 id magnum abx pf cup, lot 907690.
 
Event Description
It was reported that during a revision surgery, it was noted that the head had been cold-welded to the stem. Attempts have been made and no further information has been provided.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was confirmed by operative notes. Revision op notes were reviewed and identified that during the revision head was removed and was nearly cold welded- took extra time to remove. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined. 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.
 
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Brand NameM2A-MAGNUM 52-60MM TPR INSR +3
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8195725
MDR Text Key131382424
Report Number0001825034-2018-11488
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K011110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberN/A
Device Catalogue Number139270
Device Lot Number221770
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No

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