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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK 56X50 MAGNUM CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK 56X50 MAGNUM CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown magnum head, unknown bimetric stem, unknown taper adapter. Multiple reports were submitted along with this report: 0001825034-2021-02875, 0001825034-2021-02876. Revision notes state that the patient was revised due to loosening and a large pseudotumor was debrided. The femur had significant loosening and the surgeon had to do an osteotomy to remove the stem. Reported event was confirmed by review of medical records received. Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown. Root cause could not 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
It was reported that the patient was revised approximately 9 years later due to loosening of the acetabular and femoral components. During the revision, a large pseudotumor was debrided. All components were replaced with competitor product. No further event information available at the time of this report.
 
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Brand NameUNK 56X50 MAGNUM CUP
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 Key12638911
MDR Text Key276603984
Report Number0001825034-2021-02874
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/I
Device Lot NumberN/I
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/15/2021 Patient Sequence Number: 1
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