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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Model Number 6260-9-244
Device Problems Material Erosion (1214); Device Dislodged or Dislocated (2923)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Ambulation Difficulties (2544); Metal Related Pathology (4530)
Event Date 08/11/2020
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.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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a 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 analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Device not returned.
 
Event Description
Patient came to (b)(6) clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunion wear of the femoral stem.During surgery was noted the trunion had worn to the point that the femoral head had came off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.
 
Event Description
Patient came to cleveland clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunion wear of the femoral stem.During surgery was noted the trunion had worn to the point that the femoral head had came off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.
 
Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving a metal head was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: the metal head was not returned and no photo was provided.However, a photo of the mated stem was provided.There are scratch marks and tissue on the explanted stem.The stem trunnion was penciled.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.The event likely represents failure of a recalled lfit device.Obtaining the catalog number and/or the implants may allow confirmation.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant revealed that the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.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 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 on 27-january-2016 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.
 
Manufacturer Narrative
Reported event: an event regarding disassociation, wear/metallosis and osteolysis involving a metal head was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: the metal head was not returned and no photo was provided.However, a photo of the mated stem was provided.There are scratch marks and tissue on the explanted stem.The stem trunnion was penciled.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: a review of the provided medical records by a clinical consultant stated the following: adverse event identified: revision of left hip arthroplasty due to disassociation of a femoral head from a tmzf stem and trunnionosis.Hazards: failure of trunnion-head construct.Conclusion of assessment: review of the records provided confirmed the implant disassociation and trunnion wear.Review of implant stickers could define if the head was an lfit or associated with an lfit problem.Obtaining the implant may provide additional insight into the mechanism of disassociation.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant revealed that the event can be confirmed.The photo and the x-ray represented typical findings for failure at the taper/trunnion wear.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.
 
Event Description
Patient came to (b)(6) clinic complaining of progressive hip pain.An x-ray revealed a disassociated femoral head due to excessive trunion wear of the femoral stem.During surgery was noted the trunion had worn to the point that the femoral head had came off.After explanting the accolade tmzf stem a restoration modular stem was used as the replacement device.Update on 04-aug-2021 per medical review: ¿post-operatively it was stated that there was catastrophic failure of the hip, trunnion failure at the taper, metal disease, femoral osteolysis with a well fixed stem, wear through and destruction of the acetabulum, periacetabular osteolysis and abductor destruction.¿.
 
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Brand Name
V40 COCR LFIT HEAD 44MM/+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 Key10499267
MDR Text Key206097620
Report Number0002249697-2020-01801
Device Sequence Number1
Product Code JDI
UDI-Device Identifier07613327032758
UDI-Public07613327032758
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 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2012
Device Model Number6260-9-244
Device Catalogue Number6260-9-244
Device Lot NumberP0RMPD
Was Device Available for Evaluation? No
Date Manufacturer Received08/04/2021
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 Age73 YR
Patient Weight94
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