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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. R/B RLOC LHOLE SHL 56MM SZ 24; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. R/B RLOC LHOLE SHL 56MM SZ 24; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Positioning Failure (1158)
Patient Problem No Code Available (3191)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a hip revision procedure, a new locking ring was installed in the initial implanted shell and it would not move freely in the shell.The shell was explanted and a new shell was used to finish the procedure.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 cup / locking ring was determined to be part of a linked complaint for the same event and patient, (b)(4).This device will be reported under (b)(4).The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, the cup / locking ring was determined to be part of a linked complaint for the same event and patient, (b)(4).This device will be reported under (b)(4).The initial report was forwarded in error and should be voided.
 
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Brand Name
R/B RLOC LHOLE SHL 56MM SZ 24
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10463788
MDR Text Key204699567
Report Number0001825034-2020-03391
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K050124
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number11-106056
Device Lot Number342380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/27/2020
Supplement Dates Manufacturer Received10/28/2020
Supplement Dates FDA Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN LOCKING RING; UNKNOWN LOCKING RING
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