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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 Device Dislodged or Dislocated (2923)
Patient Problems Erosion (1750); Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown cup. Unknown liner. Unknown head. Unknown stem. The device will not 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: 0001822565-2020-00269, 0001822565-2020-00270, 0001822565-2020-00309.
 
Event Description
It was reported that a patient underwent a hip arthroplasty on an unknown date. Subsequently, the patient is being considered for a revision on an unknown day due to dislocation. X rays were received and reviewed. The results showed radiolucency. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Reported event was confirmed with x ray provided. Review of the x ray identified radiolucency and dislocation. Device history record 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameUNKNOWN HEAD
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9626938
MDR Text Key176239249
Report Number0001822565-2020-00270
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/24/2020 Patient Sequence Number: 1
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