MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0435
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
This pi is for the revision of the patient's left hip.The devices were implanted into the patient's left hip on (b)(6), 2010.Trunnion between the head and the neck was worn and metallosis was confirmed and revision surgery was performed on (b)(6), 2023.The patient was a truck driver, so the doctor comments that load may be applied to the devices when the patient got on and off the truck.The devices were not returned for inspection.
Event or Problem Description
This pi is for the revision of the patient's left hip.The devices were implanted into the patient's left hip on (b)(6) 2010.Trunnion between the head and the neck was worn and metallosis was confirmed and revision surgery was performed on (b)(6) 2023.The patient was a truck driver, so the doctor comments that load may be applied to the devices when the patient got on and off the truck.The devices were not returned for inspection.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant indicated: this patient sustained a head neck disassociation with trunnion deformity and metallosis approximately 12 1/2 years following implantation.I can confirm that this event occurred since i was able to see x-rays showing the disassociation.According to the summary the patient underwent revision surgery.I cannot confirm the revision surgery since i have no office notes, operation notes or x-rays following the revision.The causes of head neck disassociation and trunnion where and deformity are multifactorial including surgical technique factors.These could include the relatively high and medial position of the implant.Impingement may have occurred.Other causes can include patient factors such as activity level and bmi, as well as implant factors.In my opinion the patient's occupation of being a truck driver and getting on and off of his truck would not be a causative factor unless impingement occurred during these maneuvers and activities.The explanted device should be submitted to stryker engineers for analysis, evaluation and examination.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.Conclusion: it was reported that the patient was revised due to disassociation, trunnion wear and metallosis.A review of the provided medical records by a clinical consultant indicated: this patient sustained a head neck disassociation with trunnion deformity and metallosis approximately 12 1/2 years following implantation.I can confirm that this event occurred since i was able to see x-rays showing the disassociation.According to the summary the patient underwent revision surgery.I cannot confirm the revision surgery since i have no office notes, operation notes or x-rays following the revision.The causes of head neck disassociation and trunnion where and deformity are multifactorial including surgical technique factors.These could include the relatively high and medial position of the implant.Impingement may have occurred.Other causes can include patient factors such as activity level and bmi, as well as implant factors.In my opinion the patient's occupation of being a truck driver and getting on and off of his truck would not be a causative factor unless impingement occurred during these maneuvers and activities.The explanted device should be submitted to stryker engineers for analysis, evaluation and examination.Further information such as device lot number, device return and post-operative are needed to complete the investigation for determining root cause.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.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17350152
• Report Number: 0002249697-2023-00795
• Device Sequence Number: 20156092
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• 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: 2010
• 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): 11/06/2023

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: 03/31/2014
• Device Model Number: 6020-0435
• Device Catalogue Number: 6020-0435
• Device Lot Number: 29431204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 10/14/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2009
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian