MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-332
Medical Device Problem Codes	Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	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 (b)(6) hospital reporting: health canada reference #: (b)(4).
Additional 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: a review of the provided medical records by a clinical consultant indicated: confirmation of event: based upon the information supplied, i can confirm that the patient had a right total hip arthroplasty since i was able to see an operation report albeit with multiple reactions including the date.I have no information that would confirm the plan revision nor a fracture of the femoral stem.Root cause analysis: the root cause of these events cannot be determined with certainty.The root causes of trunnionosis and fracture of femoral stem are multifactorial.These include surgical technique especially in the way the trunnion and femoral head are prepared prior to insertion, positioning and achieving satisfactory fixation of the femoral stem especially to avoid "potting" of the distal portion, as well as patient factors including lifestyle, activity level and bmi, and implant factors.Consultation & discussion: no further consultation or discussion is required.-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 ¿trunnionosis of hip implant - resulting in broken implant needing to be revised surgically¿.A review of the provided medical records by a clinical consultant indicated: "based upon the information supplied, i can confirm that the patient had a right total hip arthroplasty since i was able to see an operation report albeit with multiple reactions including the date.I have no information that would confirm the plan revision nor a fracture of the femoral stem.' 'the root cause of these events cannot be determined with certainty.The root causes of trunnionosis and fracture of femoral stem are multifactorial.These include surgical technique especially in the way the trunnion and femoral head are prepared prior to insertion, positioning and achieving satisfactory fixation of the femoral stem especially to avoid "potting" of the distal portion, as well as patient factors including lifestyle, activity level and bmi, and implant factors.' no further investigation for this event is possible at this time.If 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: 32MM +8 V40 TAPER VIT HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21147482
• Report Number: 0002249697-2025-00078
• Device Sequence Number: 15727779
• Product Code: JDI
• UDI-Device Identifier: 07613327012934
• UDI-Public: 07613327012934
• 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): 05/09/2025

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: 05/31/2011
• Device Catalogue Number: 6260-5-332
• Device Lot Number: 18677303
• 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: 04/15/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2006
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown