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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8MM V40 TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH 32MM +8MM V40 TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 6264-8-332
Device Problems Sticking; Detachment of Device or Device Component; Insufficient Information
Event Date 10/20/2015
Event Type  Malfunction  
Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to manufacturer.

 
Event Description

When the surgeon does ashy knees test, the head trials are coming off trunnion and sticking inside the cup.

 
Manufacturer Narrative

The reported lot number was found to be invalid. An event regarding assembly issue involving a 32mm +8mm v40 trial head was reported. The event was not confirmed. Method & results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation. -and/or x-rays by a clinical consultant indicated: there is no specific information on the technique the surgeon uses for his trail testing. There is no evidence for any device-related problem and as such this event is not device-related. " device history review: a review of the device history records could not be performed as no lot information was provided. Complaint history review: a complaint history review could not be performed as no lot information was provided. Conclusions: medical review indicated "there is no specific information on the technique the surgeon uses for his trail testing. " there is no evidence for any device-related problem. The exact cause of the event could not be determined due to insufficient provision of information. Further information such as: return of reported device is needed to complete the investigation to determine root cause. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

When the surgeon does ashy knees test, the head trials are coming off trunnion and sticking inside the cup.

 
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Brand Name32MM +8MM V40 TRIAL 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 SUZHIOU
no. 18 wuxiang, epz zone a
200 suhong road, sip
suzhou NJ 21502 1
CN  215021
Manufacturer Contact
keyla navedo
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key5226670
Report Number0002249697-2015-03756
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6264-8-332
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/16/2015 Patient Sequence Number: 1
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