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); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture, wear & disassociation involving an unknown accolade stem was reported.The event was confirmed.Method & results: product evaluation and results: the device was not returned; however, photographs were provided for review.The photographs show a recently explanted stem with biological material.The trunnion appears to be fractured and signs of wear are also observed.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the ap x-ray dated (b)(6) 2025 shows a pressfit tha.The femoral head shows subtle angulation in regards to its position on the trunnion.The ap x-ray dated (b)(6) 2025 shows complete dissociation of the femoral head from the trunnion with considerable material loss from the proximal trunnion consistent with fracture.Trunnion fracture complete dissociation of the femoral head from the trunnion is confirmed.The root cause of this mechanical complication cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to fractured stem trunnion.A review of the provided medical records by a clinical consultant indicated: "the ap x-ray dated (b)(6) 2025 shows a pressfit tha.The femoral head shows subtle angulation in regards to its position on the trunnion.The ap x-ray dated (b)(6) 2025 shows complete dissociation of the femoral head from the trunnion with considerable material loss from the proximal trunnion consistent with fracture.Trunnion fracture complete dissociation of the femoral head from the trunnion is confirmed.The root cause of this mechanical complication cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation." the device was not returned; however, photographs were provided for review.The photographs show a recently explanted stem with biological material.The trunnion appears to be fractured and signs of wear are also observed.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.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.
Event or Problem Description
Patient was revised because the trunnion fractured.
Event or Problem Description
Patient was revised because the trunnion fractured.
Additional Manufacturer Narrative
An event regarding crack/fracture, wear & disassociation involving an accolade stem was reported.The event was confirmed.Method & results: product evaluation and results: visual: visual inspection of the returned devices indicated that the trunnion of the stem is severely worn and a piece has fractured off at the point of wear.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The stem fractured in overload at the point of wear.This has been documented as part of a capa.No further material analyses were performed.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the ap x-ray dated (b)(6) 2025 shows a pressfit tha.The femoral head shows subtle angulation in regards to its position on the trunnion.The ap x-ray dated (b)(6) 2025 shows complete dissociation of the femoral head from the trunnion with considerable material loss from the proximal trunnion consistent with fracture.Trunnion fracture complete dissociation of the femoral head from the trunnion is confirmed.The root cause of this mechanical complication cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation." 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 are no other similar events for the lot refenced.Conclusions: it was reported that the patient was revised due to fractured stem trunnion.A review of the provided medical records by a clinical consultant indicated: "the ap x-ray dated (b)(6) 2025 shows a pressfit tha.The femoral head shows subtle angulation in regards to its position on the trunnion.The ap x-ray dated (b)(6) 2025 shows complete dissociation of the femoral head from the trunnion with considerable material loss from the proximal trunnion consistent with fracture.Trunnion fracture complete dissociation of the femoral head from the trunnion is confirmed.The root cause of this mechanical complication cannot be determined from the documentation provided.Should further documentation become available i would be happy to further this investigation." the device was not returned; however, photographs were provided for review.The photographs show a recently explanted stem with biological material.The trunnion appears to be fractured and signs of wear are also observed.Visual inspection of the returned devices indicated that the trunnion of the stem is severely worn and a piece has fractured off at the point of wear.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.The stem fractured in overload at the point of wear.This has been documented as part of a capa.No further material analyses were performed.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of an nc and capa.No further investigation for this event is possible at this time.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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21357870
• Report Number: 0002249697-2025-00192
• Device Sequence Number: 8464893
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 02/28/2015
• Device Catalogue Number: 6021-3535
• Device Lot Number: 32311303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2010
• 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 Age: 81 YR
• Patient Sex: Female
• Patient Weight: 210 KG