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 Codes	Break (1069); Material Erosion (1214); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	09/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.
Event or Problem Description
As reported: "an accolade tmzf was being revised.Reason for the revision is the femoral head broke off the trunnion because of wear and fretting and possible impingement.Failure of big lfit metal head and tmzf trunnion." rep provided primary and revision usage sheets, x-ray and explant pictures.Right hip.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photos displayed a recently explanted stem with blood and dark/black tissue on it.The trunnion was significant worn with a notch in the inferior neck.There are no other conclusive remarks based on this photo.Clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a femoral stem because of disassociation of the femoral head with erosion of the trunnion with a notch in the inferior neck.I can confirm that this event took place since i have read the reported narrative and viewed an xray consistent with findings above.Regarding the possible root cause of this event, i cannot determine it with certainty.Failure of the head/neck junction is a well-known phenomenon that is multifactorial.Using a high offset with a long femoral head could be a contributing factor.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 a revision surgery took place as the femoral head broke off the trunnion because of wear and fretting and possible impingement.Clinician review of provided medical records confirmed the failure of a femoral stem because of disassociation of the femoral head with erosion of the trunnion with a notch in the inferior neck.The exact cause of the event could not be determined.Further information such as pathology reports, the 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
As reported: "an accolade tmzf was being revised.Reason for the revision is the femoral head broke off the trunnion because of wear and fretting and possible impingement.Failure of big lfit metal head and tmzf trunnion." rep provided primary and revision usage sheets, x-ray and explant pictures.Right hip.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12549652
• Report Number: 0002249697-2021-01643
• Device Sequence Number: 14733047
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• 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 Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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 Expiration Date: 11/30/2012
• Device Model Number: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: 24818106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2007
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 68 KG