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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation 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 information by a clinical consultant indicated: "the pre-revision ap x-ray demonstrates and confirms the patient had a tha with severe trunnion damage and head dissociation.The root cause of this mechanical complication cannot be determined from the limited documentation available." 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 the patient was revised due to disassociation of the head from the stem.A review of the provided medical records by a clinician indicated the following: "the pre-revision ap x-ray demonstrates and confirms the patient had a tha with severe trunnion damage and head dissociation.The root cause of this mechanical complication cannot be determined from the limited documentation available." further information such as return of the device, pathology reports, and the revision 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
It has been reported "revised stem due to trunnion damage, head disassociation.".

• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 17069111
• Report Number: 0002249697-2023-00626
• Device Sequence Number: 6129529
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/06/2023

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: 06/30/2018
• Device Model Number: 6021-3535
• Device Catalogue Number: 6021-3535
• Device Lot Number: 43821304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• 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: 76 YR
• Patient Sex: Male