MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-3535
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3 : not available.
Event or Problem Description
It was reported that a hip revision was performed for failure of an accolade stem trunnion.
Additional Manufacturer Narrative
An event regarding disassociation involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event was confirmed via medical review.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 underwent a primary cementless total hip arthroplasty with an accolade implant at some point in the past and then was found to have a head neck disassociation with trunnion failure.I can document that had neck disassociation and trunnion failure because i was able to see and x-ray with these findings.I cannot confirm that revision was carried out although the summary stated that a revision was performed.I have no documentation regarding the revision.The root cause of this event cannot be determined with certainty.The cause of head neck disassociation with trunnion failure is multifactorial.These include surgical technique factors, patient activity levels and bmi, and implant factors.If revision was carried out, the explanted prosthesis should be returned to stryker engineers for evaluation and analysis.-product history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event was confirmed through clinician review of the provided x-rays.A review of the provided medical records by a clinical consultant indicated: this patient underwent a primary cementless total hip arthroplasty with an accolade implant at some point in the past and then was found to have a head neck disassociation with trunnion failure.I can document that had neck disassociation and trunnion failure because i was able to see and x-ray with these findings.I cannot confirm that revision was carried out although the summary stated that a revision was performed.I have no documentation regarding the revision.The root cause of this event cannot be determined with certainty.The cause of head neck disassociation with trunnion failure is multifactorial.These include surgical technique factors, patient activity levels and bmi, and implant factors.If revision was carried out, the explanted prosthesis should be returned to stryker engineers for evaluation and analysis.Further information such as lot details, device return, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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 a hip revision was performed for failure of an accolade stem trunnion.Update: head disassociation has been noted.

• Brand Name: ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16937922
• Report Number: 0002249697-2023-00532
• Device Sequence Number: 12608869
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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 Model Number: 6021-3535
• Device Catalogue Number: 6021-3535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/03/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown