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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT Back to Search Results
Catalog Number 502-03-54E
Device Problems Device Disinfection Or Sterilization Issue; Difficult to Open or Remove Packaging Material; Manufacturing, Packaging or Shipping Problem
Event Date 08/19/2015
Event Type  Malfunction  
Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

 
Event Description

It was reported that during a left primary hip procedure, when the circulating nurse attempted to open the inner blister on the tritanium cup, the packaging was sticking to the foam insert of the cup and the nurse felt that the device partially lifted out of packaging and possibly touched her as a result. Another cup of same catalog and size was used and case was completed without any delay or adverse consequence to the patient.

 
Manufacturer Narrative

An event regarding a packaging issue involving a tritanium shell was reported. The event was confirmed. Method & results: device evaluation and results: the inner blister lid was stuck to the outer blister lid. It is noted that both blisters showed evidence of complete seal transfer. There is no indication that the sterility of the device was compromised. Medical records received and evaluation: not performed as the event is not related to patient factors. Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other events for this lot. Conclusions: the inner blister lid was stuck to the outer blister lid. The root cause was determined to be a known packaging issue. Packaging innovations is aware of this, and has issued a memo.

 
Event Description

It was reported that during a left primary hip procedure, when the circulating nurse attempted to open the inner blister on the tritanium cup, the packaging was sticking to the foam insert of the cup and the nurse felt that the device partially lifted out of packaging and possibly touched her as a result. Another cup of same catalog and size was used and case was completed without any delay or adverse consequence to the patient.

 
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Brand NamePRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
Type of DeviceIMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key5080912
Report Number0002249697-2015-03021
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/19/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue Number502-03-54E
Device LOT NumberR75X8J
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/10/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/08/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/16/2015 Patient Sequence Number: 1
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