MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 41MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-641
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Bipolar and head did not move smoothly.The physician changed the bipolar and head and completed the surgery.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a centrax bipolar head was reported.The event was not confirmed.Method & results: device evaluation and results: a visual inspection indicated the centrax head was received along with the corresponding metal head and locking ring.Some scratches were observed on the surface of insert.A functional inspection was performed and concluded the head rotated within the centrax head.Clinician review: not performed as medical records were not 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 as it was determined that the device was fully functional as per the functional test performed.No further investigation for this event is possible at this time.If additional information is received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Bipolar and head did not move smoothly.The physician changed the bipolar and head and completed the surgery.

• Brand Name: CENTRAX DURATION 26MM X 41MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7129914
• Report Number: 0002249697-2017-03634
• Device Sequence Number: 16536940
• Product Code: JDI
• UDI-Device Identifier: 07613327032147
• UDI-Public: 07613327032147
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2021
• Device Catalogue Number: 6226-2-641
• Device Lot Number: 447E98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other