MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DURA DURATION A/P TIB XLG 9; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	6642-1-909
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Revision of a duracon knee polyethylene insert for knee instability.Patient had a 9mm xl duracon insert implanted in (b)(6) 2000 and revised for instability of the patients knee.On (b)(6) 2019 the revision surgery was completed and successfully removed the 9mm insert replacing it with an xl 11mm insert.
Additional Manufacturer Narrative
An event regarding instability involving a duracon insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the received image of the device noted blood stains and a thread like structure at the proximal end of the device.Dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant was rejected stating - " provided x-ray does not confirm the reported event.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components." 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.Conclusions: it was reported that the patient's knee was revised for knee instability.Visual inspection of the received image of the device noted blood stains and a thread like structure at the proximal end of the device.The available medical records were provided to a consulting clinician for a review which was deemed insufficient to confirm the event.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.
Event or Problem Description
Revision of a duracon knee polyethylene insert for knee instability.Patient had a 9mm xl duracon insert implanted in (b)(6) 2000 and revised for instability of the patients knee.On (b)(6) 2019 the revision surgery was completed and successfully removed the 9mm insert replacing it with an xl 11mm insert.

• Brand Name: DURA DURATION A/P TIB XLG 9
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8417153
• Report Number: 0002249697-2019-01309
• Device Sequence Number: 19294217
• Product Code: MBH
• UDI-Device Identifier: 04546540318282
• UDI-Public: 04546540318282
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K032163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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 Catalogue Number: 6642-1-909
• Device Lot Number: VFXVA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75