MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 6226-2-650

Device Problems Failure to Align (2522); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that during a hip surgery, the surgeon could not insert the locking ring.The surgeon found that a part of insert was out of alignment.When he was adjusting the insert position with a surgical instrument, he found some black debris in the insert.He removed them and implanted the centrax.

Manufacturer Narrative

An event regarding "seating/locking issue" involving a centrax bipolar head was reported.The event was not confirmed.Method and results: -device evaluation and results: not performed as the device was not returned.-clinician review: not performed as no medical records were received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the event could not be confirmed nor the root cause could be determined because the device was not returned for evaluation and insufficient information was provided.Moreover, the black debris that were found were discarded.The implant was implanted in the patient.No further investigation for this event is possible at this time.If additional information and/or device become available, this investigation will be reopened.

Event Description

It was reported that during a hip surgery, the surgeon could not insert the locking ring.The surgeon found that a part of insert was out of alignment.When he was adjusting the insert position with a surgical instrument, he found some black debris in the insert.He removed them and implanted the centrax.

• Brand Name: CENTRAX DURATION 26MM X 50MM
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6309521
• MDR Text Key: 67110356
• Report Number: 0002249697-2017-00490
• 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: 04/20/2017

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: 05/31/2020
• Device Catalogue Number: 6226-2-650
• Device Lot Number: DD25JJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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