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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. LINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Insert
Event Date 02/07/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: unknown allofit cup, unknown head, unknown stem. Report source: foreign country: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the liner of the allofit cup could not be seated into the cup despite being hit several times. The surgery was completed with a second liner. No adverse events have been reported as a result of the malfunction. No further information has been provided.

 
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Brand NameLINER ELEVATED RIM 32 MM I.D. SIZE HH FOR USE WITH 50 MM O.D. SIZE HH SHELL
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 Key10073149
Report Number0001822565-2020-01787
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00875200932
Device LOT Number64467590
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 Received05/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/13/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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