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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN RADIAL BODY; PROSTHESIS, WRIST
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ZIMMER BIOMET, INC. UNKNOWN RADIAL BODY; PROSTHESIS, WRIST Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Patient not revised.
 
Event Description
It was reported patient has been indicated for revision due to dislocation.No revision has been reported to date.  attempts to obtain additional information have been made; however, no more is available at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) 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.
 
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Brand Name
UNKNOWN RADIAL BODY
Type of Device
PROSTHESIS, WRIST
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8491483
MDR Text Key141197166
Report Number0001825034-2019-01607
Device Sequence Number1
Product Code JWJ
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 04/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? Yes
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 Received04/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN CARPAL HEAD
Patient Outcome(s) Other;
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