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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL PROVISIONAL 54 MM O.D. INSTRUMENT, HIP

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ZIMMER BIOMET, INC. SHELL PROVISIONAL 54 MM O.D. INSTRUMENT, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Foreign report source: (b)(6). The event was confirmed with product received. Upon evaluation, the threaded bolt of the inserter is fractured. The fractured portion is seized in the shell provisional. The cup positioner and provisional exhibits wear & tear that indicates repeated use. Dhr was reviewed and no discrepancies relevant to the reported event were found. This issue was previously analyzed and identified that the design of the cup positioner adaptor cap does not allow the leading thread to be chamfered because it is needed for better engagement with smaller diameter cups. As a result, the unchamfered leading thread is and has an increased tendency to strip, deform or fracture. However, a definitive root cause could not be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04262.

 
Event Description

It was reported that during surgery, the device would not disengage from the positioner. No further event information available at the time of this report.

 
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Brand NameSHELL PROVISIONAL 54 MM O.D.
Type of DeviceINSTRUMENT, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9774941
MDR Text Key189916086
Report Number0001822565-2020-00773
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 03/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/02/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00624205400
Device LOT Number60673761
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/13/2007
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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