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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES PROSTHESIS HIP

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ZIMMER BIOMET, INC. SHELL POROUS WITH CLUSTER HOLES PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problem Component Missing
Event Date 12/11/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). (b)(6). It is unknown if product will be returning to 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 the insert installation was found that there is no locking ring on the shell. There was a delay of 35 min for removal of the shell, additionally antirotation screw was used. Attempts have been made and additional information on the reported event is unavailable at this time.

 
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Brand NameSHELL POROUS WITH CLUSTER HOLES
Type of DevicePROSTHESIS 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 Key8223762
Report Number0001822565-2019-00093
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00620005622
Device LOT Number63983677
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/07/2019 Patient Sequence Number: 1
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