MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G511
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding revision due to instability involving a triathlon insert was reported.The event was confirmed based on clinician review of the medical records provided.Method & results: device evaluation and results: not performed as no items were returned.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: gradual relaxation of remaining scar tissue after a previous revision for arthrofibrosis in 2010 when also a thinner bearing was implanted rendered the knee gradually unstable requiring another revision to restore knee stability to the immediate post primary implantation state of 2009.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: the event was confirmed based on clinician review of the medical records provided.A review of the provided medical records by a clinical consultant indicated: gradual relaxation of remaining scar tissue after a previous revision for arthrofibrosis in 2010 when also a thinner bearing was implanted rendered the knee gradually unstable requiring another revision to restore knee stability to the immediate post primary implantation state of 2009.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Left knee revision for pain and catching.Insert and patella revised.Update event based on medical review received: gradual relaxation of remaining scar tissue after a previous revision for arthrofibrosis in 2010 when also a thinner bearing was implanted rendered the knee gradually unstable requiring another revision to restore knee stability to the immediate post primary implantation state of 2009.

• Brand Name: X3 TRIATHLON CS INSERT #5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8021685
• Report Number: 0002249697-2018-03554
• Device Sequence Number: 1352699
• Product Code: MBH
• UDI-Device Identifier: 07613327045864
• UDI-Public: 07613327045864
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2018

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: 03/31/2015
• Device Catalogue Number: 5531G511
• Device Lot Number: LBU975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/30/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 127