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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Metal Related Pathology (4530)
Event Date 11/09/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00228.
 
Event Description
It was reported that the patient underwent a revision procedure due to pain and elevated cobalt levels. During the revision, grayish fluid and debris was encountered. The acetabular and femoral components were found to be well-fixed and the trunnion in good condition. The femoral head was replaced with a dual mobility without complication. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN 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 Key13397457
MDR Text Key284808755
Report Number0001825034-2022-00229
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/10/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/31/2022
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 Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2008
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: 01/31/2022 Patient Sequence Number: 1
Treatment
CAT#: 157446 M2A HEAD LOT#: 442760; UNKNOWN STEM
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