MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6226-2-642

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, 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.

Event Description

It was reported that, a surgeon noticed a gap (2mm) between locking ring and shell.A spare centrax was implanted instead.Update: "there was a gap (2mm) between the locking ring and acetabular shell.".

• Brand Name: CENTRAX DURATION 26MM X 42MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: collin neitzel ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8707625
• MDR Text Key: 148292228
• Report Number: 0002249697-2019-02288
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032154
• UDI-Public: 07613327032154
• Combination Product (y/n): N
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 6226-2-642
• Device Lot Number: R35M2N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2018
• 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: 66 YR