MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CENTRAX DURATION 26MM X 43MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6226-2-643
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
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 reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that, during a bha, there was a foreign material on the device.
Event or Problem Description
It was reported that, during a bha, there was a foreign material on the device.
Additional Manufacturer Narrative
An event regarding foreign matter involving a centrax head was reported.The event was confirmed.Method & results: device evaluation and results: the device was not returned as the device has been implanted but the blister tray was returned.A piece of material was taped on the blister tray.A material analysis was performed on the returned foreign material taped on the blister tray.Material analysis concluded that "foreign debris was reportedly observed on the centrax duration.Ftir analysis indicated the debris was consistent with poly(methyl methacrylate).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the reported event for the foreign matter was confirmed based on the returned foreign material taped on the blister tray.The device was used and implanted onto the patient.A material analysis was performed on the returned foreign material taped on the blister tray.Material analysis concluded that "foreign debris was reportedly observed on the centrax duration.Ftir analysis indicated the debris was consistent with poly(methyl methacrylate).Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." a root cause could not be determined based on the consultation with packaging sme indicating that the mar test result showed that the foreign material was pmma, but their packaging process do not use pmma material.No further investigation is needed at this time.If additional information are received, this investigation will be reopened and re-evaluated.

• Brand Name: CENTRAX DURATION 26MM X 43MM
• 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: 8092086
• Report Number: 0002249697-2018-03797
• Device Sequence Number: 1458647
• Product Code: JDI
• UDI-Device Identifier: 07613327032161
• UDI-Public: 07613327032161
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 04/30/2023
• Device Catalogue Number: 6226-2-643
• Device Lot Number: WY89K7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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