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	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	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to stem breakage.
Additional Manufacturer Narrative
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.H3 other text : not returned to the manufacturer.
Event or Problem Description
Revision surgery due to stem breakage.
Additional Manufacturer Narrative
An event regarding wear and disassociation involving an accolade stem was reported.The event was confirmed via evaluation of the returned devices.Method & results: product evaluation and results: visual inspection: the device was returned for evaluation.Damages an scratches are visible along the body of the stem and the trunnion of the stem was severely worn.Damage is consistent with the loss of taper lock.Clinician review: a review of the provided medical records by a clinical consultant indicated: "undated/unlabeled: ap pelvis x-ray.Very poor quality film with tha on one side with what appears to be metal in metal construct and accolade tmzf stem.Stem fracture is not apparent but cannot be ruled out due to the poor image.Conclusion/assessment: the report notes a stem breakage and revision surgery approximately 14 years after implantation.No medical records or adequate imaging were provided for review.Event confirmation: the event cannot be confirmed due to lack of medical information or interpretable imaging.Root cause: cannot be determined as the event cannot be confirmed." 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 the patient was revised due to stem breakage.The device was returned for evaluation.Visual inspection of the returned device indicated that the trunnion of the stem was severely worn.The observed damage is consistent with the loss of taper lock.A review of the provided x-ray image by a clinician yielded no significant findings due to the poor quality of the x-ray film.Further information such as pathology reports, additional pre- and post-operative x-rays and the revision 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 becomes 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18083235
• Report Number: 0002249697-2023-01349
• Device Sequence Number: 15100879
• Product Code: LPH
• UDI-Device Identifier: 04546540510754
• UDI-Public: 04546540510754
• 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: 2009
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 08/31/2014
• Device Catalogue Number: 6021-3535
• Device Lot Number: 30845106
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2009
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 71 KG