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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 50 HEAD V40 TAPER HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 50 HEAD V40 TAPER HIP IMPLANT Back to Search Results
Catalog Number UNK_REC
Device Problems Device Operates Differently Than Expected; Device Contamination with Chemical or Other Material; Naturally Worn; Insufficient Information
Event Date 09/02/2015
Event Type  Injury  
Manufacturer Narrative

The catalog number and lot code were not provided. The device was reported as an unknown 50 head v40 taper. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

 
Event Description

The surgeon reported that he undertook revision surgery of an accolade stem, mitch bearing and a v40 taper head allegedly as a result of failed stem. During surgery black debris was noted around the implant and the surgeon reported that the trunnion looked as though it had worn away into a bullet shape. The representative was present in the case and it was not clear to him whether the trunnion had snapped altogether. The date of original surgery was 2008. The patient presented with a history of pain in the hip circa 9 months duration, prior to the revision.

 
Manufacturer Narrative

An event regarding wear involving an unknown head was reported. The event was not confirmed. Method & results: -device evaluation and results: not performed as the device was not returned. -medical records received and evaluation: not performed as medical records were not provided. -device history review: a review of the device history records could not be performed as device details were not provided. -complaint history review: a complaint history review could not be performed as device details were not provided conclusions: the exact cause of the event could not be determined because insufficient information was provided. Further information such as operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further. If additional information and/or device become available, this investigation will be reopened.

 
Event Description

The surgeon reported that he undertook revision surgery of an accolade stem, mitch bearing and a v40 taper head allegedly as a result of failed stem. During surgery black debris was noted around the implant and the surgeon reported that the trunnion looked as though it had worn away into a bullet shape. The representative was present in the case and it was not clear to him whether the trunnion had snapped altogether. The date of original surgery was 2008. The patient presented with a history of pain in the hip circa 9 months duration, prior to the revision.

 
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Brand NameUNKNOWN 50 HEAD V40 TAPER
Type of DeviceHIP IMPLANT
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 Key5114771
Report Number0002249697-2015-03200
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_REC
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 Received10/20/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/30/2015 Patient Sequence Number: 1
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