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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

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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 Problem Corroded (1131)
Patient Problems Metal Related Pathology (4530); Insufficient Information (4580)
Event Date 02/10/2022
Event Type  Injury  
Event Description
It was reported by counsel that patient underwent left tha on (b)(6) 2018, and was implanted with an lfit anatomic v40 femoral head and accolade ii hip stem.He was revised on (b)(6) 2022, allegedly due to corrosion.
 
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.H3 other text : not returned.
 
Manufacturer Narrative
Reported event: an event regarding corrosion involving an 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.-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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to corrosion.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 revision 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
It was reported by counsel that patient underwent left tha on (b)(6) 2018 and was implanted with an lfit anatomic v40 femoral head and accolade ii hip stem.He was revised on (b)(6) 2022 allegedly due to corrosion.
 
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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
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
anna ryan
raheen business park
limerick, NJ NA
EI   NA
2018315000
MDR Report Key18450459
MDR Text Key332172557
Report Number0002249697-2024-00028
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/26/2024
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 Date07/31/2022
Device Catalogue Number6260-9-240
Device Lot NumberJNLTYP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/14/2023
Initial Date FDA Received01/05/2024
Supplement Dates Manufacturer Received01/31/2024
Supplement Dates FDA Received02/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/10/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age73 YR
Patient SexMale
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