MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 10 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-1040
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.H3 other text : not returned.
Event or Problem Description
Left hip revision for pain and elevated cobalt levels.Cocr head replaced with a universal taper sleeve and ceramic head, insert exchanged to an eccentric.
Event or Problem Description
Left hip revision for pain and elevated cobalt levels.Cocr head replaced with a universal taper sleeve and ceramic head, insert exchanged to an eccentric.
Additional Manufacturer Narrative
An event regarding corrosion and abnormal ion level involving an accolade stem was reported.The event for corrosion was confirmed.Method & results: -product evaluation and results: the device was not returned; however, a photo of the implanted stem was provided for review.The photo shows the stem implanted with what appears to be corrosion material in the taper.Clinician review: a review of the provided medical records by a clinical consultant indicated: conclusion/assessment: by report a revision tha was performed for pain and increased metal levels.Photographs of the femoral head and trunnion at the time of the revision showed a small amount of black corrosion material in the taper.No clinical history, documents, pre or postoperative course, or laboratory reports were provided for review.Event confirmation: a revision procedure can be confirmed.Pain, elevated cobalt levels, replacement with a universal taper sleeve and ceramic head, and liner exchange cannot be confirmed without additional medical records.Root cause: the root cause of the revision was reported to be pain and increased metal levels, but these could not be confirmed.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.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 patient was revised due to pain and elevated cobalt levels.A review of the provided medical records by a clinical consultant indicated: conclusion/assessment: by report a revision tha was performed for pain and increased metal levels.Photographs of the femoral head and trunnion at the time of the revision showed a small amount of black corrosion material in the taper.No clinical history, documents, pre or postoperative course, or laboratory reports were provided for review.Event confirmation: a revision procedure can be confirmed.Pain, elevated cobalt levels, replacement with a universal taper sleeve and ceramic head, and liner exchange cannot be confirmed without additional medical records.Root cause: the root cause of the revision was reported to be pain and increased metal levels, but these could not be confirmed.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SIZE 10 ACCOLADE II 127 DEG
• 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: 17883685
• Report Number: 0002249697-2023-01141
• Device Sequence Number: 17973666
• Product Code: LPH
• UDI-Device Identifier: 04546540669551
• UDI-Public: 04546540669551
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/09/2024

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: 04/30/2023
• Device Catalogue Number: 6721-1040
• Device Lot Number: 62880603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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: 83 YR
• Patient Sex: Male