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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP PROSTHESIS, HIP Back to Search Results
Catalog Number US157858
Device Problems Material Erosion (1214); Failure to Osseointegrate (1863); Loss of Osseointegration (2408)
Patient Problems Adhesion(s) (1695); Erosion (1750); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Blood Loss (2597)
Event Date 02/18/2019
Event Type  Injury  
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. Once the investigation has been completed, a follow-up mdr will be submitted concomitant medical products: part # 139270 / taper / lot # 799680, part # 157452 / m2a head / lot # 139710, part # 12-103208 /stem/ lot # 266410. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01401, 0001825034 -2020 -01402, 0001825034 -2020 -01403.
 
Event Description
It was reported that patient underwent hip revision surgery 13 years post implantation due to pain and elevated metal ion levels. During the revision, the acetabular shell was found to be grossly loose with bone erosion posterior to the cup which has limited ingrowth. After additional scar tissue was removed, the stem remained intact but all other components were revised without complications. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records. The device history records were reviewed and no discrepancies were identified. A definitive root cause could not be determined with the information provided. 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
No further event information available at the time of this report.
 
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Brand NameM2A-MAGNUM PF CUP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9904371
MDR Text Key187363629
Report Number0001825034-2020-01400
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Type of Report Initial,Followup
Report Date 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2016
Device Catalogue NumberUS157858
Device Lot Number138930
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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