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

Catalog Number	6021-3535
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	05/10/2024
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.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.
Event or Problem Description
It was reported the patient had a hip revision due to disassociation.It was also noticed the trunnion was worn.
Event or Problem Description
It was reported the patient had a hip revision due to disassociation.It was also noticed the trunnion was worn.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation & wear involving an accolade stem that was mated with a lfit v40 cocr head was reported.The event was confirmed via medical review.Method & results: -device evaluation and results: the device was not returned for review; however, photographs were provided.The photographs show a recently explanted stem covered in blood and an extremely worn trunnion.-clinician review: a review of the provided medical records by a clinical consultant indicated: "it was reported the patient had a hip revision due to disassociation.It was also noticed the trunnion was worn.The right tha ap x-ray documents a stem head dissociation.There is significant trunnion deformity with superior material loss on the trunnion.Dissociation of the femoral head from the stem is confirmed as is trunnion deformation.The root cause of the dissociation and trunnion material loss cannot be determined from the limited documentation provided.Should further documentation become available i would be happy to further this investigation." -device 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 of the head from the stem.A review of the provided medical records by a clinical consultant indicated: "it was reported the patient had a hip revision due to disassociation.It was also noticed the trunnion was worn.The right tha ap x-ray documents a stem head dissociation.There is significant trunnion deformity with superior material loss on the trunnion.Dissociation of the femoral head from the stem is confirmed as is trunnion deformation.The root cause of the dissociation and trunnion material loss cannot be determined from the limited documentation provided.Should further documentation become available i would be happy to further this investigation." the device was not returned for review; however, photographs were provided.The photographs show a recently explanted stem covered in blood and an extremely worn trunnion.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.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.

• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19483923
• Report Number: 0002249697-2024-00848
• Device Sequence Number: 8029825
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 10/31/2011
• Device Catalogue Number: 6021-3535
• Device Lot Number: 20451202
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2006
• 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 Sex: Unknown