MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK SIZE 7 ACCOLADE II 132 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 6720-0737

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

It was reported that the patient's left hip was revised for a periprosthetic fracture of the femur.The femoral head was revised to a new head and sleeve with 3 sets of cables.Rep confirmed there were no allegations against the revised femoral head, and that no further information will be released by the hospital or surgeon.

• Brand Name: SIZE 7 ACCOLADE II 132 DEG
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• Manufacturer Contact: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10483500
• MDR Text Key: 205322910
• Report Number: 0002249697-2020-01792
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540664501
• UDI-Public: 04546540664501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2022
• Device Model Number: 6720-0737
• Device Catalogue Number: 6720-0737
• Device Lot Number: 59974005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 105