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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
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 relevant reported discrepancies.There have been no other similar 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 during the procedure, locking ring was not assembled into bipolar and the surgeon tried some times but locking ring was not assembled.The bipolar cup was changes to one size bigger one and the problem was solved.
Additional Manufacturer Narrative
An event regarding an assembly issue involving a centrax head was reported.The event was not confirmed.Method & results: product evaluation and results: the centrax head with catalog number 6626-2-652 and lot k46drv was returned for evaluation.Scratches are visible on the head.Damage is also visible on the outer rim of the head.The damage is consistent with attempted implantation and subsequent explantation of the device.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock on with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the centrax head with catalog number 6626-2-652 and lot k46drv was returned for evaluation.Scratches are visible on the head.Damage is also visible on the outer rim of the head.The damage is consistent with attempted implantation and subsequent explantation of the device.The event itself cannot be confirmed as insufficient information was provided.It is noted that when bipolar cup was changed to one size bigger the problem was solved.Further information such images and/or video of the event taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that during the procedure, locking ring was not assembled into bipolar and the surgeon tried some times but locking ring was not assembled.The bipolar cup was changes to one size bigger one and the problem was solved.

• 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: 8687189
• Report Number: 0002249697-2019-02219
• Device Sequence Number: 16880954
• 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): 08/19/2019

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: 05/31/2023
• Device Catalogue Number: 6226-2-652
• Device Lot Number: K46DRV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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