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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH 32MM STD LFIT V40 HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6260-9-132
Device Problems Shipping Damage or Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem
Event Date 12/06/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

Powder substance on femoral head and inside packaging.

 
Manufacturer Narrative

An event regarding white debris involving a metal femoral head was reported. The event was confirmed. Method & results: device evaluation and results: debris was identified on the returned metal head. Damage was also noted to the inner blister post. Medical records received and evaluation: no medical records were received for review with a clinical consultant and no adverse consequences to the patient were noted. Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar events for the reported lot. Conclusions: an nc investigation was opened for the manufacturing investigation. Some residue was noted on taper as indicated in the event description. Damage to the post also noted. It was deemed that the 'powder' on the femoral head was residue from the broken petg post. The investigation concluded packaging design was the root cause.

 
Event Description

Powder substance on femoral head and inside packaging.

 
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Brand Name32MM STD LFIT V40 HEAD
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
cindy chuhinko
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key6224066
Report Number0002249697-2017-00077
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device Catalogue Number6260-9-132
Device LOT Number45502001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/20/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2013
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: 01/04/2017 Patient Sequence Number: 1
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