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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. TRILOGY ACETABULAR SYSTER BONE SCREW 6.5X20 SELF-TAP PROSTHESIS, HIP

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ZIMMER, INC. TRILOGY ACETABULAR SYSTER BONE SCREW 6.5X20 SELF-TAP PROSTHESIS, HIP Back to Search Results
Catalog Number 00625006520
Device Problems Device Packaging Compromised; Difficult to Open or Remove Packaging Material
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). (b)(4). (b)(6). The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not. Once this information is obtained a follow-up mdr will be submitted. Product location unknown.

 
Event Description

It was reported that the tyvek of the inner sterile packaging was in-between the tyvek of the outer sterile packaging. This made opening the package correctly not possible. No adverse events have been reported as a result of the malfunction.

 
Manufacturer Narrative

Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number. This event will be reported on 0002648920 - 2018 - 00711.

 
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Brand NameTRILOGY ACETABULAR SYSTER BONE SCREW 6.5X20 SELF-TAP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key6734488
Report Number0001822565-2017-04972
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue Number00625006520
Device LOT Number63530641
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/23/2016
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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