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

Model Number	6077-0637
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
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 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.Device not returned.
Event or Problem Description
Dr.Revised a unipolar hip of the right side due to femoral fracture.Original surgery was (b)(6) 2020.
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: 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: confirmation: a periprosthetic fracture around an accolade style stem and endo-prosthetic head can be confirmed.Implant logs indicate a revision surgery was performed.Root cause: the root cause cannot be confirmed.Medical history to include hospital records, pre- and postoperative x-rays, would likely answer the root cause question.Without additional information the cause of the fracture and the date / time of the fracture cannot be assessed.The fracture appears to have occurred in the postoperative period (pi report / staple in x-ray), the cause of the fracture is unclear.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.Conclusions: a periprosthetic fracture around an accolade style stem and endo-prosthetic head was confirmed through clinician review of the provided medical records.The root cause cannot be confirmed.Additional information such as medical history to include hospital records, pre- and postoperative x-rays 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.H3 other text : device not returned.
Event or Problem Description
Dr.Revised a unipolar hip of the right side due to femoral fracture.Original surgery was on (b)(6) 2020.

• Brand Name: ACCOLADE HFX SIZE #6
• 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: 11001580
• Report Number: 0002249697-2020-02663
• Device Sequence Number: 19008650
• Product Code: LPH
• UDI-Device Identifier: 07613327021226
• UDI-Public: 07613327021226
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K051741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 01/31/2022
• Device Model Number: 6077-0637
• Device Catalogue Number: 6077-0637
• Device Lot Number: KH3MNA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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: 88 YR