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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 Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).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 is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00150.
 
Event Description
It was reported the screw did not enter the screw hole of the cup.Another screw was used.No adverse events were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
Upon reassessment of the reported event, the cup was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon reassessment of the reported event, the cup was determined to be not reportable and did not contribute to the reported event.The initial report was forwarded in error and should be voided.
 
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Brand Name
UNKNOWN CUP
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9779926
MDR Text Key189915534
Report Number0001822565-2020-00798
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 company representative,foreig
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
ZIMMER SCREW CAT# 00625006515, LOT# 64348067
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