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U.S. Department of Health and Human Services

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

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ZIMMER MANUFACTURING B.V. TRILOGY ACETABULAR SYSTER BONE SCREW 6.5X20 SELF-TAP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Difficult to Open or Remove Packaging Material; Packaging Problem
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. (b)(4). Foreign source: (b)(6). Complaint sample was evaluated and the reported event was not confirmed. Visual evaluation of the returned carton box, patient labels and sealed inner cavity found no visible evidence that the inner tyvek was sealed into the outer cavity tyvek seal as the outer cavity and seal were not returned for review. Device history record (dhr) was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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

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.

 
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Brand NameTRILOGY ACETABULAR SYSTER BONE SCREW 6.5X20 SELF-TAP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7924094
Report Number0002648920-2018-00711
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 10/01/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00625006520
Device LOT Number63530641
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? Device Not Returned To Manufacturer
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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