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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 26MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH 26MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 6260-5-226
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem Insufficient Information (4580)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
After inserting the stem into the femur and firmly driving the inner head reported this time, surgeon inserted a bipolar cup and tried to reduce it.Then, the inner head was disengaged from the stem rolled down to the outside.So the head became dirty.The bipolar cup and inner head were raised one size.
 
Manufacturer Narrative
Reported event: an event regarding seating/locking issues involving a metal head was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection of the returned device noted the following: visual inspection of the returned device identified nothing remarkable to report.Dimensional inspection: the device is dimensionally within specification as per inspection completed by manufacturing cell representative.Inspection report attached.Functional inspection: functional inspection of the returned device noted the following: material analysis: not performed as this event does not relate to material integrity.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
After inserting the stem into the femur and firmly driving the inner head reported this time, surgeon inserted a bipolar cup and tried to reduce it.Then, the inner head was disengaged from the stem rolled down to the outside.So the head became dirty.The bipolar cup and inner head were raised one size.
 
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Brand Name
26MM +4 V40 TAPER VIT HEAD
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key11832625
MDR Text Key250945233
Report Number0002249697-2021-00864
Device Sequence Number1
Product Code JDI
UDI-Device Identifier07613327012880
UDI-Public07613327012880
Combination Product (y/n)N
PMA/PMN Number
K173499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6260-5-226
Device Catalogue Number6260-5-226
Device Lot Number77226603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age59 YR
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