MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 8 ACCOLADE II 132 DEG; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	6720-0837
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.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.
Event or Problem Description
Femoral shaft fracture of total right hip.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed through a review of the provided medical records by a clinical consultant.Method & results: -device evaluation and results: not performed as product was not returned -medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: {.} - device-related factors play no role in pp-fracture problems because the problem is located in the bone around the device and materials and/or manufacturing aspects of the device play no role in pp-fracture failure scenarios.It was confirmed during revision that all components were intact.The stem was exchanged only because it had become loose due to the fracture and stability of the new device requires a longer stem to bypass and stabilize the fractured bone area.This pi case is not device-related.Procedure-related factors: - none.Patient-related factors - patient trauma or adverse movement.Device-related factors: - none.Diagnosis: - a traumatic overload condition of external origin has contributed to a periprosthetic fracture around the accolade ii stem requiring revision.{.} -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.Conclusions: the investigation concluded that the periprosthetic fracture was caused by {.} a traumatic overload condition of external origin has contributed to a periprosthetic fracture around the accolade ii stem requiring revision.{.}.
Event or Problem Description
Femoral shaft facture of total right hip.

• Brand Name: SIZE 8 ACCOLADE II 132 DEG
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7161646
• Report Number: 0002249697-2018-00031
• Device Sequence Number: 10781409
• Product Code: LPH
• UDI-Device Identifier: 04546540664518
• UDI-Public: 04546540664518
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2021
• Device Catalogue Number: 6720-0837
• Device Lot Number: 55528703
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/21/2018
• 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: 70 YR
• Patient Weight: 109