MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 47MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6226-2-647

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Device Slipped (1584)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/25/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The locking ring came off after the operation and revision surgery was performed on (b)(6) 2015.

Manufacturer Narrative

An event regarding a disassociation of the locking ring involving a centrax duration 26mm x 47mm was reported.The event was confirmed.Method & results: - device evaluation: the device was returned with the locking ring disassociated and the tabs to the inner insert were deformed.- medical records received and evaluation: the xray confirms dislocated hip however, op reports, clinical/past medical history were needed to provide a meaningful dictation for this case.- device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.- complaint history review: there have been no other events for the lot referenced.Conclusions: the event was confirmed however the root cause of the reported disassociation could not be determined due to the combination of lack of medical records and the fact that the device was damaged.If additional medical records were to be received, this investigation will be reopened.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available, this investigation will be reopened.

Event Description

The locking ring came off after the operation and revision surgery was performed on (b)(6) 2015.

• Brand Name: CENTRAX DURATION 26MM X 47MM
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5175427
• MDR Text Key: 29196343
• Report Number: 0002249697-2015-03438
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 09/25/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 6226-2-647
• Device Lot Number: A14C225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2014
• 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): Required Intervention