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

Model Number	6226-2-641
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a bha, the centrax did not slide smoothly on the head.A spare centrax was used instead.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a centrax bipolar was reported.The event was not confirmed.The device was received centrax head was received along with the corresponding locking ring and packaging clip.No damage was observed on any of the components.A functional test was performed and indicated there is resistance when rotating the head within the centrax head.A functional using a gauge cannot be performed as head was returned assembled with the centrax head.Clinician review: not performed as medical records were not received for review with a clinical consultant.All devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.A functional test was performed and indicated there is resistance when rotating the head within the centrax head.A functional using a gauge cannot be performed as head was returned assembled with the centrax head.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
It was reported that, during a bha, the centrax did not slide smoothly on the head.A spare centrax was used instead.

• 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: 6533637
• Report Number: 0002249697-2017-01418
• Device Sequence Number: 16144798
• Product Code: JDI
• UDI-Device Identifier: 07613327032147
• UDI-Public: (01)07613327032147(11)160421(17)210430(10)JK5LAD
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: 04/30/2021
• Device Model Number: 6226-2-641
• Device Catalogue Number: 6226-2-641
• Device Lot Number: JK5LAD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 09/18/2017
• 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