MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-2530
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/23/2020
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 through clinician review of the provided medical records.Method & results: product evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: event date: (b)(6) 2020 (opened: (b)(6) 2020).Anatomic site: right hip.Event description: the patient underwent the initial surgery on (b)(6) 2020 at other hospital.On (b)(6) 2020 the patient underwent revision surgery at the reporting hospital due to dislocation.The reporting sr explained to the surgeon that the plastic neck was possibly wore because it was a case with large head of 36mm or more, the patient was in high activity, and high offset.Implants: mom cup 44mm head, 52mm cup for 44mm head, modular v40 modular head 44mm 8mm, accolade 1270 size 2.5 tmzf.Documents reviewed: 12/23/2020: stryker pi report: undated ap pelvis x-ray accolade tmzf and large mom on right, well fixed with some acetabular lysis.(b)(6) 2020: ap pelvis with disengaged or broken stem head junction.Event confirmation: the event was confirmed.There was disengagement or fracture at the neck/head junction.Root cause: the root cause cannot be ascertained.There was clearly disengagement or fracture at the neck/head junction.Operative notes, intraoperative findings and any retrieved implants may be helpful in defining the mode of failure.The pi report mentions a "plastic" neck.I am unfamiliar with any implant with a plastic neck.Also, the dates provided showed a "dislocation" 6 weeks after the primary.It would be very unlikely for significant wear to occur at this early time point.Note, on the x-ray there may be some deformation at the neck/trunnion but this is difficult to assess on a single view x-ray.Product 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.Conclusions: the event of disassociation was confirmed through clinician review of the provided medical records which indicated: the event was confirmed.There was disengagement or fracture at the neck/head junction.Root cause: the root cause cannot be ascertained.There was clearly disengagement or fracture at the neck/head junction.Operative notes, intraoperative findings and any retrieved implants may be helpful in defining the mode of failure.The pi report mentions a "plastic" neck.I am unfamiliar with any implant with a plastic neck.Also, the dates provided showed a "dislocation" 6 weeks after the primary.It would be very unlikely for significant wear to occur at this early time point.Note, on the x-ray there may be some deformation at the neck/trunnion but this is difficult to assess on a single view x-ray.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.
Event or Problem Description
The patient underwent the initial surgery on (b)(6) 2020 at other hospital.On (b)(6) 2020 the patient underwent revision surgery at the reporting hospital due to dislocation.The reporting sr explained to the surgeon that the plastic neck was possibly wore because it was a case with large head of 36mm or more, the patient was in high activity, and high offset.Update january 25, 2021: there was disengagement or fracture at the neck/head junction.

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11274373
• Report Number: 0002249697-2021-00205
• Device Sequence Number: 4831226
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 53