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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN HEAD 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 06/08/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown stem, unknown taper. Multiple reports were submitted along with this report: 0001825034-2021-01645. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device not returned for evaluation.
 
Event Description
It was reported that the patient underwent an initial left total hip arthroplasty on an unknown date. Subsequently, patient was revised due to pain and muscle/tissue damage due to metallosis. During the revision procedure the surgeon noted a rupture of the gluteus minimus and bursa tissue with draining hole through the gluteus medius through the gluteus minimus. The acetabular head and taper were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN HEAD
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 Key11929709
MDR Text Key254250309
Report Number0001825034-2021-01644
Device Sequence Number1
Product Code KWA
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,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
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 Received07/28/2021
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: 06/03/2021 Patient Sequence Number: 1
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