MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 22.2MM X 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6226-2-246
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.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.
Event or Problem Description
Three months after the bha for femoral neck fracture, the image showed that the metal head came off from the centrax bipolar cup during reduction.After revision, no damage was found on the bipolar cup.
Event or Problem Description
Three months after the bha for femoral neck fracture, the image showed that the metal head came off from the centrax bipolar cup during reduction.After revision, no damage was found on the bipolar cup.
Additional Manufacturer Narrative
An event regarding dislocation involving a centrax bipolar head was reported.The event was not confirmed.Method & results: product evaluation and results: the metal head and bipolar head were returned for evaluation.There are some black dots on the poly section of the bipolar device.The device was damaged from attempted implantation/explantation and/or the dislocation event.The polyethylene liner is deformed, and the space between the polyethylene and the metal shell is filled with what appears to be bone debris.Dimensional & functional inspection: functional and dimensional inspections were not performed as the device was returned damaged from attempted implantation/explantation and/or the dislocation event.The polyethylene liner is deformed, and the space between the polyethylene and the metal shell is filled with what appears to be bone debris.Functional and/or dimensional testing of the device in this state would not be representative of the manufactured state of the device.No further testing is required.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the metal head came off from the centrax bipolar cup during reduction.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: CENTRAX DURATION 22.2MM X 46MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12715959
• Report Number: 0002249697-2021-01802
• Device Sequence Number: 14512947
• Product Code: JDI
• UDI-Device Identifier: 07613327032048
• UDI-Public: 07613327032048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 04/05/2022
• Device Model Number: 6226-2-246
• Device Catalogue Number: 6226-2-246
• Device Lot Number: L82E9A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 48 KG