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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 48ODX42ID PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Pain (1994); Metal Related Pathology (4530)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: cat# 157442 lot# 831010 m2a-magnum mod hd, cat# 139254 lot# 000880 m2a-magnum 42-50mm, cat# 11-104111 lot# 814590 mlry-hd por fmrl. Complaint sample was evaluated and the reported event was confirmed. Visual examination of the returned product identified the devices remain assembled upon receipt. Visual inspection found scratching on the exposed surface of the insert. The taper is etched -3. Dark debris and scuffing are present inside the taper of the insert. Scratching was observed on the outside of the head in multiple locations. The head is etched 42. Device history record (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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-10510, 0001825034-2018-10508, 0001825034-2018-11559.
 
Event Description
It was reported the patient underwent a revision approximately 10 years post initial surgery for ongoing pain, discomfort, mild metalosis, elevated ions, and mild trunnionosis with collected fluid around the hip. No additional information.
 
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Brand NameM2A-MAGNUM PF CUP 48ODX42ID
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 Key14305653
MDR Text Key291485846
Report Number0001825034-2022-01153
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062995
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2017
Device Model NumberN/A
Device Catalogue NumberUS157848
Device Lot Number724930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2007
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: 05/06/2022 Patient Sequence Number: 1
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