MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6721-0635
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/07/2021
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 that the patient's right hip was revised due to a femoral periprosthetic fracture suffered in a fall.An accolade ii stem was revised.Rep confirmed there are no allegations against any revised implants.Rep also confirmed he can provide primary and revision usage, and that no further information will be released by the hospital or surgeon.A second rep attempting to report the same event provided x-rays and usage sheets, and also confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed through 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 stated the following comment: undated: ap hip left x-ray, accolade ii stem and uncemented shell some lucency around shell, but no significant abn.Undated: ap hip left x-ray, accolade ii stem with subsidence and fracture of the lesser troch and subtroch region.(b)(6) /2021: implant usage sheet, 48 mm-d trident ii tritanium shell clusterhole, 22.2mm +0 lfit head, #6 accolade ii stem 1270, 38mm-d mdm liner, 22.2mm x3 mdm liner 38-d.(b)(6) 2021: implant usage sheet, 22.2 mm+3mm lfit v40 head, 22.2 38mm-38d mdmx3 polyethylene insert, 25mm +0 v40 restoration modular, 155mm x20mm stem restoration modular, 3x 2.0 dall miles cables.Confirmation: a periprosthetic fracture can be confirmed around an accolade ii stem.The revision can only be confirmed insofar as implants were logged for the procedure.The etiology, and history cannot be confirmed without additional medical records.Root cause: the root cause cannot be confirmed without additional medical records.The pi report showed an alleged fall an implied the trauma led to the fracture.This cannot be confirmed without additional records.This style and timing of fracture can also be associated with intraoperative causes.Here are no obvious links to the implants as a root cause.-product history review: indicated all 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: the medical review indicated: a periprosthetic fracture can be confirmed around an accolade ii stem.The revision can only be confirmed insofar as implants were logged for the procedure.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary 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 become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to a femoral periprosthetic fracture suffered in a fall.An accolade ii stem was revised.Rep confirmed there are no allegations against any revised implants.Rep also confirmed he can provide primary and revision usage, and that no further information will be released by the hospital or surgeon.A second rep attempting to report the same event provided x-rays and usage sheets, and also confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: SIZE 6 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
• MDR Report Key: 12092659
• Report Number: 0002249697-2021-01114
• Device Sequence Number: 20058144
• Product Code: LPH
• UDI-Device Identifier: 04546540669513
• UDI-Public: 04546540669513
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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: 05/31/2026
• Device Model Number: 6721-0635
• Device Catalogue Number: 6721-0635
• Device Lot Number: 84731701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 72