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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HIPSTAR V40 STEM N 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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STRYKER ORTHOPAEDICS-MAHWAH HIPSTAR V40 STEM N 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS Back to Search Results
Catalog Number 7850-1-004
Device Problems Decoupling (1145); Material Fragmentation (1261); Material Separation (1562); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Ambulation Difficulties (2544)
Event Date 12/21/2017
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
 
Event Description
The patient arrived on (b)(6) 2017 at the hospital for an acute coaxalgia secondary to decoupling of the prosthetic femoral components, implanted in 2009.The femoral head, the stem and the insert were replaced with a revision surgery on (b)(6) 2017.
 
Manufacturer Narrative
An event regarding disassociation involving a hipstar stem was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted hipstar stem whereby wear of the trunnion is evident.From the photographs provided there is evidence of disassociation for the device.Dimensional inspection: not performed as the device was not returned.Functional inspection: not performed as the device was not returned.Material analysis: not performed as the device was not returned.-medical records received and evaluation: not performed as no medical records were received.Device history review: not performed as lot details provided are invalid.Complaint history review: not performed as lot details provided are invalid.Conclusions: the exact cause of the event could not be determined because insufficient information was provided and the device was not returned.Further information such as product evaluation, pre- and post-operative x-rays, operative reports as well as follow-up notes are needed to complete the investigation for determining a root cause.
 
Event Description
The patient arrived on (b)(6) 2017 at the hospital for an acute coaxalgia secondary to decoupling of the prosthetic femoral components, implanted in 2009.The femoral head, the stem and the insert were replaced with a revision surgery on (b)(6) 2017.
 
Event Description
The patient arrived on (b)(6) 2017 at the hospital for an acute coaxalgia secondary to decoupling of the prosthetic femoral components, implanted in 2009.The femoral head, the stem and the insert were replaced with a revision surgery on (b)(6) 2017.
 
Manufacturer Narrative
Correction: update to implant date and patient information.An event regarding disassociation and metallosis involving a hipstar stem was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted hipstar stem whereby wear/taper of the trunnion is evident.-clinician review: a review of the provided medical records by a clinical consultant indicated: [.] right hip revision surgery was performed on (b)(6) 2017.Upon exploration, a severe metallosis was reported with the disassociation confirmed.¿wear and damage¿ of both cup bearing and stem trunnion were reported.An explant photograph during revision confirms severe metal substance loss of the trunnion with a typical ¿pencil-shape¿ deformity.The hipstar stem appeared well-ingrown and required a femoral osteotomy for removal.The stem was replaced with a stryker restoration modular stem with 36-mm/-5 ceramic head and new 36-mm/+10° x3 insert.The cup shell was retained.The femoral osteotomy was stabilised with three 2-mm dall-miles cables.[.]concerning the other findings of metal substance loss on the trunnion with metallosis and quite likely elevated cobalt andchrome levels in the blood, these findings should be considered secondary to an overload condition in thearthroplasty, quite likely as a consequence of component malposition as discussed.At this time however,the reported evidence is too thin to draw such a conclusion with an adequate level of confidence.As such,actual x-rays are urgently required to further clarify this case.-device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review indicateda review of the provided medical records by a clinical consultant indicated: [.] right hip revision surgery was performed on dec 21, 2017.Upon exploration, a severe metallosis was reported with the disassociation confirmed.¿wear and damage¿ of both cup bearing and stem trunnion were reported.An explant photograph during revision confirms severe metal substance loss of the trunnion with a typical ¿pencil-shape¿ deformity.The hipstar stem appeared well-ingrown and required a femoral osteotomy for removal.The stem was replaced with a stryker restoration modular stem with 36-mm/-5 ceramic head and new 36-mm/+10° x3 insert.The cup shell was retained.The femoral osteotomy was stabilised with three 2-mm dall-miles cables.[.]concerning the other findings of metal substance loss on the trunnion with metallosis and quite likely elevated cobalt and chrome levels in the blood, these findings should be considered secondary to an overload condition in thearthroplasty, quite likely as a consequence of component malposition as discussed.At this time however,the reported evidence is too thin to draw such a conclusion with an adequate level of confidence.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as x-rays are required to completed the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
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Brand Name
HIPSTAR V40 STEM N 4
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7259566
MDR Text Key99583952
Report Number0002249697-2018-00379
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
K051223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2013
Device Catalogue Number7850-1-004
Device Lot NumberG2661058
Was Device Available for Evaluation? No
Date Manufacturer Received03/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
Patient Weight77
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