MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM 0 OFFSET; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	6260-9-136
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.This event was reported to stryker canada by health canada via mandatory hospital reporting: health canada reference #: (b)(4).
Additional Manufacturer Narrative
An event regarding disassociation and wear involving a metal head was reported.The event was not confirmed.Method & results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of provided medical records with a clinical consultant indicated "conclusion/assessment: patient underwent a tha for oa.It appeared uncomplicated.Patient was discharged without apparent incident.No radiographs, pre or postoperative medical history were provided for review.All records provided were without dates or labels.By pi report alone trunnionosis developed and led to revision surgery for a broken implant.The implants were an accolade stem #4 1320, trident cluster shell with x3 liner, and 36 mm+0m lfit head.Event confirmation: tha with an lfit-accolade combination can be confirmed.No other events can be confirmed as there were no records to support the pi report claims.Root cause: the root cause for the tha was oa of the right hip.A root cause for the revision cannot be ascertained as the event cannot be confirmed.A root cause for trunnionosis cannot be ascertained as the event cannot be confirmed.The root cause for implant breakage cannot be ascertained as the event cannot be confirmed.-device 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 has been no other similar event for the lot referenced conclusions: a review of provided medical records with a clinical consultant indicated "conclusion/assessment: patient underwent a tha for oa.It appeared uncomplicated.Patient was discharged without apparent incident.No radiographs, pre or postoperative medical history were provided for review.All records provided were without dates or labels.By pi report alone trunnionosis developed and led to revision surgery for a broken implant.The implants were an accolade stem #4 1320, trident cluster shell with x3 liner, and 36 mm+0m lfit head.Event confirmation: tha with an lfit-accolade combination can be confirmed.No other events can be confirmed as there were no records to support the pi report claims.Root cause: the root cause for the tha was oa of the right hip.A root cause for the revision cannot be ascertained as the event cannot be confirmed.A root cause for trunnionosis cannot be ascertained as the event cannot be confirmed.The root cause for implant breakage cannot be ascertained as the event cannot be confirmed.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 or Problem Description
It was reported that ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.This event was reported to stryker canada by health canada via mandatory hospital reporting: health canada reference #: (b)(4).

• Brand Name: V40 COCR LFIT HEAD 36MM 0 OFFSET
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21160990
• Report Number: 0002249697-2025-00086
• Device Sequence Number: 20962576
• Product Code: JDI
• UDI-Device Identifier: 07613327032307
• UDI-Public: 07613327032307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 6260-9-136
• Device Lot Number: MLE4M9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown