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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRILOGY POROUS ACETABULAR SHELL PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TRILOGY POROUS ACETABULAR SHELL PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Udi: (b)(4). Report source: (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. 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.

 
Event Description

Hold for tyonie 12/19/17 it was reported that the locking ring was missing from the package. No adverse events have been reported as a result of the malfunction.

 
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Brand NameTRILOGY POROUS ACETABULAR 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 Key7109582
MDR Text Key95577342
Report Number0001822565-2017-08484
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberPK934765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00620005222
Device LOT Number63691912
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/15/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/30/2017
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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