Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 40MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 6260-9-240
Device Problems Degraded (1153); Device Dislodged or Dislocated (2923)
Patient Problems Ossification (1428); Injury (2348); Ambulation Difficulties (2544)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.Device not returned.
 
Event Description
It was reported that: "revision right total hip.The 40mm v40 taper cocr femoral head fell off the accolade tmzf stem.Original surgery was 2012.No additional information for this case.The primary surgery was done at another hospital.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation & corrosion involving unknown metal head was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: heterotopic ossifications in and around the joint space in concert with a moderate overweight condition and larger head size have contributed to an overload condition in the arthroplasty to cause corrosion with ultimately loss of taper lock functionality and disassociation of the femoral head from the trunnion requiring revision surgery.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that patient's revision of right total hip due to disassociation and corrosion.The event was confirmed based on medical review.A review of the provided medical records and x-rays by a clinical consultant indicated: heterotopic ossifications in and around the joint space in concert with a moderate overweight condition and larger head size have contributed to an overload condition in the arthroplasty to cause corrosion with ultimately loss of taper lock functionality and disassociation of the femoral head from the trunnion requiring revision surgery.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
 
Event Description
It was reported that: "revision right total hip.The 40mm v40 taper cocr femoral head fell off the accolade tmzf stem.Original surgery was 2012.No additional information for this case.The primary surgery was done at another hospital.".
 
Manufacturer Narrative
Reported event: an event regarding disassociation & corrosion involving metal head was reported.The event was confirmed based on medical review.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: "principal cause of failure is contributed by the cup malposition of the right hip in low inclination and probably also low anteversion.This is a procedure-related factor because the surgeon is responsible for optimal component position.The choice for a 40-mm femoral head, also a procedure-related factor because of surgical decision making, might be mentioned as a relevant secondary factor because increase in head size is associated with an increase in angular speed in the bearing thereby increasing bearing friction.This may magnify the adverse effects of any present overload conditions although with perfect positioned components this would certainly not have represented a relevant failure introduction factor just by itself.From the patient-related perspective no major factors are evident.There was only a mild overweight condition with a bmi of 28 (25 max normal) and this should not be considered a relevant contributing factor.Also from the device-related perspective, there is no evidence to suggest that device-related factors might have contributed to the problem" device history review: all 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 reported lot.Conclusion: it was reported that patient's revision of right total hip due to disassociation and corrosion.The event was confirmed based on medical review.The subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall ra 2016-028 was initiated for the lfit v40 cocr heads within scope of this nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.Corrective action/preventive action: an nc was initiated due to the occurrence rate for taper lock failure in the risk management files for specific lots of lfit v40 cocr heads.Given the potential risk of nine (9) hazards identified in the hazards and harm evaluation, voluntary product recall ra 2016-028 was issued.
 
Event Description
It was reported that: "revision right total hip.The 40mm v40 taper cocr femoral head fell off the accolade tmzf stem.Original surgery was 2012.No additional information for this case.The primary surgery was done at another hospital." update: "it was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his right hip on or about (b)(6)2007 and was revised on (b)(6) 2020.It is further alleged that intraoperative findings consisted of dissociation of the cobalt chrome head from the worn stem trunnion with bird beak pattern.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
V40 COCR LFIT HEAD 40MM/+4
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10413108
MDR Text Key203103375
Report Number0002249697-2020-01668
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K173499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2012
Device Catalogue Number6260-9-240
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/17/2020
Supplement Dates Manufacturer Received09/22/2020
08/16/2021
Supplement Dates FDA Received10/19/2020
09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2249697-08/29/2016-007R
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age68 YR
Patient Weight79
-
-