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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK SHELL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNK SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Metal Related Pathology (4530)
Event Date 03/02/2022
Event Type  Injury  
Event Description
It was reported the patient underwent a metal on metal magnum 2a hip revision conversion to active articulation for metallosis. No additional information.
 
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00603.
 
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Brand NameUNK SHELL
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 Key13800444
MDR Text Key287414285
Report Number0001825034-2022-00604
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2022
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: 03/17/2022 Patient Sequence Number: 1
Treatment
UNK M2A HEAD; UNK TAPER ADAPTOR
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