MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-4535
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	09/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem that was mated with an lfit v40 cocr head 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 records by a clinical consultant indicated: 'confirmation of event: i can confirm that the patient had a primary total hip arthroplasty as described above since i was able to see the original stryker stickers.I can also confirm that the patient underwent revision surgery because i was able to review the operation report.I can confirm the operative findings of head neck decoupling with what was described as findings consistent with trunnionosis and metallosis.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of head neck decoupling with wear of the trunnion with metallosis are multifactorial.These includes surgical technique factors especially in the way the femoral head and femoral trunnion are prepared prior to insertion of the final implants, patient factors including lifestyle, activity level and bmi, and implant factors' -product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that 'the preoperative diagnosis was "right total hip arthroplasty failure femoral component" and the postoperative diagnosis was "decoupling head and neck with metallosis right total hip arthroplasty.' a review of the provided medical records by a clinical consultant indicated: 'i can confirm that the patient had a primary total hip arthroplasty as described above since i was able to see the original stryker stickers.I can also confirm that the patient underwent revision surgery because i was able to review the operation report.I can confirm the operative findings of head neck decoupling with what was described as findings consistent with trunnionosis and metallosis.' 'the root cause of this event cannot be determined with certainty.The causes of head neck decoupling with wear of the trunnion with metallosis are multifactorial.These includes surgical technique factors especially in the way the femoral head and femoral trunnion are prepared prior to insertion of the final implants, patient factors including lifestyle, activity level and bmi, and implant factors' the mated cocr head has been identified to be within scope of nc and capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Letter received from an attorney alleging that patient had hip explanted on (b)(6) 2015.Unknown hip implants were revised for unknown reason and attorney is requesting devices be returned.Update: the preoperative diagnosis was "right total hip arthroplasty failure femoral component" and the postoperative diagnosis was "decoupling head and neck with metallosis right total hip arthroplasty.".

• Brand Name: ACCOLADE (127 DEG) SIZE 4.5 ACCOLADE (127 DEG) SIZE 4.5
• 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: 23439871
• Report Number: 0002249697-2025-01274
• Device Sequence Number: 18310789
• Product Code: LPH
• UDI-Device Identifier: 04546540510761
• UDI-Public: 04546540510761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: 04/30/2010
• Device Catalogue Number: 6021-4535
• Device Lot Number: 12853102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2005
• 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: 80 YR
• Patient Sex: Male