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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-M / L TAPER-STEMS-UNK PROSTHESIS, HIP

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ZIMMER BIOMET, INC. HIP-M / L TAPER-STEMS-UNK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Failure of Implant (1924); Local Reaction (2035); Metal Related Pathology (4530)
Event Date 08/23/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). It is unknown at this time if the device will be returned for analysis, due to location of device is unknown; 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: 0001822565-2021-00901.
 
Event Description
It was reported that the patient underwent a revision procedure due to elevated cobalt levels, significant soft tissue extension and metallosis. They have significant findings of cystic degenerative changes inclusive of around the psoas and soft tissue thickening in the capsule and pericapsular tissues. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameHIP-M / L TAPER-STEMS-UNK
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 Key11590721
MDR Text Key243066646
Report Number0001822565-2021-00900
Device Sequence Number1
Product Code KWY
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
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
Event Location No Information
Date Manufacturer Received04/30/2021
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: 03/30/2021 Patient Sequence Number: 1
Treatment
HIP-OTHER-HEADS-UNK
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