MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 6226-2-642

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/26/2018

Event Type  Injury  

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.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.The following devices were also listed in this report: cat# 6721-0435; size 4 accolade ii 127 deg; lot# 66189301.Cat# 6260-5-026; 26mm -3 v40 taper vit head; lot# 66336504.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Neurovascular disorder on (b)(6) 2018.Treated with ortop.Update april 29, 2021: this event was reported as multicenter results survey at bha and provided by clinical.According to surgeon, neurovascular disorder is related to procedure.But it is unknown if it is related to device or only procedure.It can be ¿causal relationship¿ is unknown, too.

• Brand Name: CENTRAX DURATION 26MM X 42MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11784817
• MDR Text Key: 249303901
• Report Number: 0002249697-2021-00808
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07613327032154
• UDI-Public: 07613327032154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K972792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 6226-2-642
• Device Catalogue Number: 6226-2-642
• Device Lot Number: E76JN9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• 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): Other
• Patient Age: 77
• Patient Weight: 37