MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6226-2-650
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
On an unknown date, the patient underwent bha procedure.On unknown date after bha the bipolar cup was dislocated, and on (b)(6) 2020, "tthe" revision was performed (the bipolar cap and the inner head were revised).The reporting surgeon¿s opinion: it was first case that only the bipolar cap was dislocated.There was a possibility that locking had not been done properly at the initial bha.But the cause was unknown.The reporting sr¿s opinion: the inner polyethylene of the bipolar cap was found to be deformed after the removal.It was unknown if this was the cause of the event.But please investigate why it was deformed and the cause of dislocation.
Additional Manufacturer Narrative
Additional information: lot information received.An event regarding dislocation involving a centrax head was reported.The event was confirmed.Method & results: device evaluation and results: material analysis was not performed as this is not related to material integrity.Damage visible consistent with autoclaving of polymeric devices.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
On an unknown date, the patient underwent bha procedure.On unknown date after bha the bipolar cup was dislocated, and on (b)(6) 2020, tthe revision was performed (the bipolar cap and the inner head were revised).The reporting surgeon¿s opinion: it was first case that only the bipolar cap was dislocated.There was a possibility that locking had not been done properly at the initial bha.But the cause was unknown.The reporting sr¿s opinion: the inner polyethylene of the bipolar cap was found to be deformed after the removal.It was unknown if this was the cause of the event.But please investigate why it was deformed and the cause of dislocation.

• Brand Name: CENTRAX DURATION 26MM X 50MM
• 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: 9834670
• Report Number: 0002249697-2020-00531
• Device Sequence Number: 14004554
• Product Code: JDI
• UDI-Device Identifier: 07613327032239
• UDI-Public: 07613327032239
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 6226-2-650
• Device Catalogue Number: 6226-2-650
• Device Lot Number: RM8JP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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: Hospitalization; Required Intervention