MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 45MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-645
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates 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 or Problem Description
When a doctor set femoral head into bipolar cup, he found the movement of the femoral head in bipolar was not smooth.It seemed to be tighter than usual.
Additional Manufacturer Narrative
An event regarding a size/fit issue involving a centrax duration head was reported.The event was not confirmed.Device evaluation and results: visual inspection: the centax head was returned assembled with the metal head.The device was otherwise unremarkable.Dimensional inspection: a dimensional inspection could not be performed as the centrax head and metal head were returned assembled and could not be disassembled.Disassembling the device would affect the dimensional integrity.A review of the dhr confirmed that all devices passed dimensional inspection.Functional inspection: the centrax head and metal head were returned assembled.No functional issue was noted.Medical records received and evaluation: no information was received for review with a clinical consultant.No adverse impact to patient was noted.Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined, the centrax head and metal head could not be disassembled.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
When a doctor set femoral head into bipolar cup, he found the movement of the femoral head in bipolar was not smooth.It seemed to be tighter than usual.

• Brand Name: CENTRAX DURATION 26MM X 45MM
• 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: 6668853
• Report Number: 0002249697-2017-02027
• Device Sequence Number: 11255978
• Product Code: JDI
• UDI-Device Identifier: 07613327032192
• UDI-Public: 07613327032192
• 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: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2022
• Device Catalogue Number: 6226-2-645
• Device Lot Number: 6V3AE9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 10/07/2017
• 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