MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 6 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0635
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	12/03/2019
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.A provided x-ray shows a periprosthetic femoral fracture however, cause has not been established.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
As reported: "traumatic (slip and fall on ice) periprosthetic [femoral] fracture.Implanted competitor stem, body, and head.Implanted stryker liner 10° 36mm f, competitor cables and 5-hole trochanteric plate.Cup and screws intact.
Additional Manufacturer Narrative
An event regrading periprosthetic fracture involving an accolade stem was reported.The event was confirmed.Method & results: device evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: x-ray provided confirms periprosthetic fracture, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Device history review: 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 reported lot.Conclusion: the event of periprosthetic fracture was confirmed based on the clinician review of the provided x-ray.Although the patient sustained a fall the exact cause cannot be confirmed based on the information provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are required to complete the investigation and determine a root cause.No further investigation 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
As reported: "traumatic (slip and fall on ice) periprosthetic [femoral] fracture.Implanted competitor stem, body, and head.Implanted stryker liner 10° 36mm f, competitor cables and 5-hole trochanteric plate.Cup and screws intact.

• Brand Name: SIZE 6 ACCOLADE II 132 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: 9531991
• Report Number: 0002249697-2019-04137
• Device Sequence Number: 14147655
• Product Code: LPH
• UDI-Device Identifier: 04546540664495
• UDI-Public: 04546540664495
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: 03/31/2019
• Device Model Number: 6720-0635
• Device Catalogue Number: 6720-0635
• Device Lot Number: 46971603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/05/2020
• 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: 74 YR