MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-648
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.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, during a bha, a head did not slide smoothly on the sliding surface of the centrax.Another centrax(under 1 mm) was used instead.The head slid smoothly in the spare one.
Event or Problem Description
It was reported that, during a bha, a head did not slide smoothly on the sliding surface of the centrax.Another centrax(under 1 mm) was used instead.The head slid smoothly in the spare one.
Additional Manufacturer Narrative
Reported event: an event regarding "size/fit issue" involving a centrax bipolar was reported.The event was not confirmed.Method & results: device evaluation and results: a functional test was performed with the returned device along with a 26mm std lfit v40 head, catalog 6260-9-126, lot: 62522102, and an accolade (127 deg) sample, catalog w6021-0335 were obtained from finished goods.The returned device was readily assembled to these components with normal hand force and without any undue effort.Once assembled, the head freely rotated in the returned centrax insert as expected.The device was deemed to be conforming and therefore, the reported event could not be duplicated.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.It was noted in the reported event that another centrax (under 1mm)was used.No further investigation for this event is possible at this time.If additional information is received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: CENTRAX DURATION 26MM X 48MM
• 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: 8547198
• Report Number: 0002249697-2019-01705
• Device Sequence Number: 2431242
• Product Code: JDI
• UDI-Device Identifier: 07613327032215
• UDI-Public: 07613327032215
• Combination Product (Y/N): N
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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: 11/30/2023
• Device Catalogue Number: 6226-2-648
• Device Lot Number: 1E0WL9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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: 83 YR