MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-5-232
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); Metal Related Pathology (4530)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The neck of the accolade tmzf was damaged due to wear, which caused the metal head to come off.Metalosis was also confirmed during revision surgery.
Additional 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.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation, wear & metallosis involving a metal head was reported.The event was confirmed.Method & results: -product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted head covered in blood.There is nothing else to report.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty with an accolade implant and a metal femoral head and then approximately eight years later underwent revision for trunnionosis, metallosis and had neck disassociation.I can confirm that the patient developed head neck disassociation with the above associated findings since i was able to see x-rays and gross specimens.The root cause of this event cannot be determined with certainty.The causes of trunnionosis, metallosis and head neck disassociation are multifactorial including surgical technique factors especially preparation of the trunnion and femoral head when implanted, patient factors such as activity level and bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination to see if any defects were present." -product history review: 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.It was reported that the patient was confirmed due to disassociation, wear and metallosis.A review of the provided medical records by a clinical consultant indicated: "this case concerns a patient who underwent a cementless total hip arthroplasty with an accolade implant and a metal femoral head and then approximately eight years later underwent revision for trunnionosis, metallosis and had neck disassociation.I can confirm that the patient developed head neck disassociation with the above associated findings since i was able to see x-rays and gross specimens.The root cause of this event cannot be determined with certainty.The causes of trunnionosis, metallosis and head neck disassociation are multifactorial including surgical technique factors especially preparation of the trunnion and femoral head when implanted, patient factors such as activity level and bmi, and implant factors.The explanted prostheses should be submitted to stryker engineers for metallurgical analysis and examination to see if any defects were present." the device was not returned; however, photographs were provided for review.The photographs show a recently explanted head covered in blood.There is nothing else to report.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 or Problem Description
The neck of the accolade tmzf was damaged due to wear, which caused the metal head to come off.Metalosis was also confirmed during revision surgery.

• Brand Name: 32MM +4 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17609800
• Report Number: 0002249697-2023-00926
• Device Sequence Number: 20438587
• Product Code: JDI
• UDI-Device Identifier: 07613327012903
• UDI-Public: 07613327012903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 6260-5-232
• Device Lot Number: 38443001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2011
• 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