MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6720-0330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	08/22/2019
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.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.
Event or Problem Description
The patient underwent right total hip replacement (b)(6) 2019.Patient had a fall and right femur periprosthetic fracture.The patient underwent right hip revision, femoral component and ceramic head were exchanged (b)(6) 2019.
Event or Problem Description
Procedure: the patient underwent right total hip replacement (b)(6) 2019.Patient had a fall and right femur periprosthetic.Fracture.The patient underwent right hip revision, femoral component and ceramic head were exchanged (b)(6) 2019.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a size 3 accolade ii 132 deg was reported.The event was confirmed through medical review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation.A review of the provided medical records by a clinical consultant stated the following comment: "another ap and lateral of the right hip labeled ¿pre-revision¿ demonstrates an uncemented right total hip arthroplasty with no screws in the acetabulum.The hip is reduced and a proximal femoral fracture is noted." "no clinical or past medical history, no patient demographics, and no examination of explanted components are available for review.There is no evidence this early post-operative clinical event was related to factors associated with implant manufacturing or materials." product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: although it was reported that the patient suffered from a fall, the exact cause of the periprosthetic fracture could not be determined because insufficient information was provided.While a fall was reported as a possible cause, the event cannot be confirmed.Further information such as return of the device, pathology reports, 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 3 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: 9659138
• Report Number: 0002249697-2020-00207
• Device Sequence Number: 19525034
• Product Code: LPH
• UDI-Device Identifier: 04546540664464
• UDI-Public: 04546540664464
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 04/30/2024
• Device Model Number: 6720-0330
• Device Catalogue Number: 6720-0330
• Device Lot Number: 70449502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: 67 YR