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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HIP-OTHER-HEADS-UNK; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. HIP-OTHER-HEADS-UNK; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
(b)(4).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: 0001822565-2021-00884.0001822565-2021-00885.0001822565-2021-00887.
 
Event Description
It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, the head was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, the head was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
HIP-OTHER-HEADS-UNK
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11590017
MDR Text Key242995906
Report Number0001822565-2021-00886
Device Sequence Number1
Product Code KWY
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 07/29/2021
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? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
HIP-OTHER-CUPS-UNK; HIP-OTHER-LINERS-UNK; HIP-OTHER-STEMS-UNK; HIP-OTHER-CUPS-UNK; HIP-OTHER-LINERS-UNK; HIP-OTHER-STEMS-UNK
Patient Outcome(s) Other;
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