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 Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
Event or Problem Description
It was reported that, during a bha, a surgeon found a deformed insert in the shell.A spare was used instead.As per additional information received; one of the 8 tabs of insert was shifted toward the center.It was noticed when the surgeon was trying to combine it with the head.
Event or Problem Description
It was reported that, during a bha, a surgeon found a deformed insert in the shell.A spare was used instead.As per additional information received; one of the 8 tabs of insert was shifted toward the center.It was noticed when the surgeon was trying to combine it with the head.
Additional Manufacturer Narrative
Additional information: device return and retuned date.An event regarding damage involving a centrax liner was reported.The event was confirmed following visual inspection.Visual inspection: visual inspection was performed by a member of the mar team.This inspection noted: "damage observed on one of the tabs, consistent with contact against a hard object.Based on the given information, no observed materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: 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 are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

• 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: 7711976
• Report Number: 0002249697-2018-02269
• Device Sequence Number: 19044547
• 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): 10/10/2018

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: 07/31/2020
• Device Catalogue Number: 6226-2-652
• Device Lot Number: Y480JT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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