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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 6260-9-236
Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); Ambulation Difficulties (2544)
Event Date 06/09/2022
Event Type  Injury  
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.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.H3 other text : device not returned.
 
Event Description
It was reported by patient's attorney that allegedly he was implanted with an accolade tmzf hip stem and lfit cocr v40 femoral head on his right hip on (b)(6) 2011, and was revised on (b)(6) 2022.It is further alleged that x-ray taken in the er showed a disassociation between the femoral head and the femoral stem.
 
Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: 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: it was reported that the patient was revised due to disassociation of the head from the stem.The subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall pfa 1757583 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
It was reported by patient's attorney that allegedly he was implanted with an accolade tmzf hip stem and lfit cocr v40 femoral head on his right hip on (b)(6) 2011, and was revised on (b)(6) 2022.It is further alleged that x-ray taken in the er showed a disassociation between the femoral head and the femoral stem.
 
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Brand Name
V40 COCR LFIT HEAD 36MM/+5
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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
anna ryan
raheen business park
limerick NA
EI   NA
61498200
MDR Report Key17687324
MDR Text Key322696383
Report Number0002249697-2023-00989
Device Sequence Number1
Product Code JDI
UDI-Device Identifier07613327032314
UDI-Public07613327032314
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/13/2023
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 Date03/31/2016
Device Catalogue Number6260-9-236
Device Lot NumberMKDA3T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/05/2023
Supplement Dates Manufacturer Received10/18/2023
Supplement Dates FDA Received11/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2249697-05/07/2018-003R
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age81 YR
Patient SexMale
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