MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-0230
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by mps: "i covered a hip revision today due to trunnionosis failure in the right hip w/ dislocation (head dissociation)." spoke to mps.A stem, head and liner were revised.Explant picture for the liner shows damage on the rim.The mps cannot confirm if that damage was present in situ or if it is explant damage.
Event or Problem Description
It was reported that the patient's right hip was revised.As reported by mps: "i covered a hip revision today due to trunnionosis failure in the right hip w/ dislocation (head dissociation)." spoke to mps.A stem, head and liner were revised.Explant picture for the liner shows damage on the rim.The mps cannot confirm if that damage was present in situ or if it is explant damage.
Additional Manufacturer Narrative
An event regarding disassociation and trunnionosis involving a accolade stem was reported.The event of disassociation was confirmed but trunnionosis was not.Method & results -product evaluation and results: visual inspection: the device was not returned however photographs were provided for review.A review of the provided photographs indicated recently explanted devices covered in blood and tissue.Explantation damage observed on the insert.There is nothing remarkable on the head and stem.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records with a clinical consultant indicated "this inquiry presents a case of femoral head disassociation and reported trunnionosis.This process occurs between the trunnion of the femoral implant and the femoral head.As i mentioned above causes of this phenomenon are multifactorial including surgical technique, patient factors and implant factors.I can confirm that the event of disassociation occurred because i was able to review an x-ray which showed disassociation.I cannot confirm trunnionosis with the information provided.I cannot confirm the root cause for certain.The causes of disassociation are multifactorial as i noted above." -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported the patient was revised due to disassociation of the head and stem and trunnionosis.The device was not returned however photographs were provided for review.A review of the provided photographs indicated recently explanted devices covered in blood and tissue.Explantation damage observed on the insert.There is nothing remarkable on the head and stem.A review of medical records with a clinical consultant indicated "this inquiry presents a case of femoral head disassociation and reported trunnionosis.This process occurs between the trunnion of the femoral implant and the femoral head.As i mentioned above causes of this phenomenon are multifactorial including surgical technique, patient factors and implant factors.I can confirm that the event of disassociation occurred because i was able to review an x-ray which showed disassociation.I cannot confirm trunnionosis with the information provided.I cannot confirm the root cause for certain.The causes of disassociation are multifactorial as i noted above."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.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14839526
• Report Number: 0002249697-2022-00935
• Device Sequence Number: 4743855
• Product Code: LPH
• UDI-Device Identifier: 04546540510679
• UDI-Public: 04546540510679
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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 Model Number: 6021-0230
• Device Catalogue Number: 6021-0230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 81 YR
• Patient Sex: Male