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

Catalog Number 6260-9-236

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/14/2023

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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.H3 other text : not returned.

Event Description

Left hip revision for pain and elevated cobalt levels.Cocr head replaced with a universal taper sleeve and ceramic head, insert exchanged to an eccentric.

Manufacturer Narrative

An event regarding abnormal ion level and corrosion involving a metal head was reported.The event for corrosion was confirmed.Method & results: product evaluation and results: the device was not returned for investigation; however, photographs were provided for review.The photo shows a recently explanted metal head with some implantation/explantation damage.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: by report a revision tha was performed for pain and increased metal levels.Photographs of the femoral head and trunnion at the time of the revision showed a small amount of black corrosion material in the taper.No clinical history, documents, pre or postoperative course, or laboratory reports were provided for review.Event confirmation: a revision procedure can be confirmed.Pain, elevated cobalt levels, replacement with a universal taper sleeve and ceramic head, and liner exchange cannot be confirmed without additional medical records.Root cause: the root cause of the revision was reported to be pain and increased metal levels, but these could not be confirmed.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.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 patient was revised due to pain and elevated cobalt levels.A review of the provided medical records by a clinical consultant indicated: conclusion/assessment: by report a revision tha was performed for pain and increased metal levels.Photographs of the femoral head and trunnion at the time of the revision showed a small amount of black corrosion material in the taper.No clinical history, documents, pre or postoperative course, or laboratory reports were provided for review.Event confirmation: a revision procedure can be confirmed.Pain, elevated cobalt levels, replacement with a universal taper sleeve and ceramic head, and liner exchange cannot be confirmed without additional medical records.Root cause: the root cause of the revision was reported to be pain and increased metal levels, but these could not be confirmed.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Left hip revision for pain and elevated cobalt levels.Cocr head replaced with a universal taper sleeve and ceramic head, insert exchanged to an eccentric.

• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17883626
• MDR Text Key: 325061543
• Report Number: 0002249697-2023-01140
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032314
• UDI-Public: 07613327032314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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 Catalogue Number: 6260-9-236
• Device Lot Number: EK7N27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male