MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-652
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the v40 head was not locked to the centrax cup.Therefore, the cup and head were changed to new devices.
Additional Manufacturer Narrative
Device evaluated by mfg.An event regarding assembly issue involving a centrax bipolar head was reported.The event was not confirmed.Visual inspection was performed as part of the material analysis report (mar).The returned devices were examined with the aid of a stereo microscope at magnifications up to 50x.No significant damage was observed on the surfaces of the metal shell.The insert was observed to have a displaced tab consistent with attempted assembly of the components.The ring was observed to have material displacement along the rim on the proximal surface and on the distal surface consistent with attempted assembly of the components.A material analysis has been performed.The report concluded: no significant damage was observed on the metal shell.The insert and the ring were observed to have damage consistent with attempted assembly of the components.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were returned for review.A review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.There were no other events for the lot provided.The mar concluded: no significant damage was observed on the metal shell.The insert and the ring were observed to have damage consistent with attempted assembly of the components.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was received.Further information such the primary operative is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the v40 head was not locked to the centrax cup.Therefore, the cup and head were changed to new devices.

• Brand Name: CENTRAX DURATION 26MM X 52MM
• 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: 7409731
• Report Number: 0002249697-2018-01064
• Device Sequence Number: 1143960
• Product Code: JDI
• UDI-Device Identifier: 07613327032253
• UDI-Public: 07613327032253
• 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): 06/25/2018

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: 12/31/2022
• Device Catalogue Number: 6226-2-652
• Device Lot Number: 9A4RHW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 06/25/2018
• 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
• Patient Age: 79 YR