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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER STANDARD OFFSET PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. LINER STANDARD OFFSET PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Shipping Damage or Problem (1570)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Product has been received by 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 by the distributor the product arrived damaged with sterility barrier potentially compromised. There was no patient involvement.

 
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Brand NameLINER STANDARD OFFSET
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 Key8417801
MDR Text Key138771037
Report Number0002648920-2019-00198
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK002960
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/13/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00630505836
Device LOT Number63916376
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/01/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/01/2018
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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