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 Codes	Device Operates Differently Than Expected (2913); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The movement of the head was too bad.So used another product.
Additional Manufacturer Narrative
An event regarding a size/fit issue involving a centax bipolar head was reported.The event was not confirmed.Device evaluation and results: visual inspection: the centrax bipolar head had scratches on the articulating surface.The device was otherwise visually unremarkable.Dimensional inspection: a dimensional inspection of the centrax bipolar head could not be performed due to damage observed during visual inspection, in addition the act of disassembling the centrax bipolar head from the metal head will alter the device dimensions.Therefore an accurate dimensional inspection of the disassembled centrax bipolar head is not possible.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.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
The movement of the head was too bad.So used another product.

• 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: 6846444
• Report Number: 0002249697-2017-02684
• Device Sequence Number: 1522203
• 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): 11/08/2017

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: 06/15/2022
• Device Catalogue Number: 6226-2-645
• Device Lot Number: A159WE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/08/2017
• 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