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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 54ODX48ID HIP PROSTHESIS

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 54ODX48ID HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Death (1802); Pain (1994); Discomfort (2330); Reaction (2414)
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 remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 11-103207, stem, lot # 814200, item # 157448, head, lot # 623530, item # 139252, taper insert, lot # 630740. Legal notification. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-08515, 0001825034-2018-08516.
 
Event Description
It was reported that a patient was implanted left hip with mom devices approximately 10 years ago and developed elevated ion levels. The patient expired on x(date) from heart and renal failure. Attempts have been made, and no further information has been provided.
 
Manufacturer Narrative
This report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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 54ODX48ID
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7818031
MDR Text Key118277403
Report Number0001825034-2018-08515
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PK042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Model NumberN/A
Device Catalogue NumberUS157854
Device Lot Number451430
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/27/2018 Patient Sequence Number: 1
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