MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G613
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left knee was revised due to instability.A 6x13 cs insert was revised to a 6x16 cs x3 insert.The surgeon noted that the poly had some yellowing and would like to ensure that it is not oxidation.The explant is available for return, and the rep confirmed that no further information will be available.
Event or Problem Description
It was reported that the patient's left knee was revised due to instability.A 6x13 cs insert was revised to a 6x16 cs x3 insert.The surgeon noted that the poly had some yellowing and would like to ensure that it is not oxidation.The explant is available for return, and the rep confirmed that no further information will be available.
Additional Manufacturer Narrative
An event regarding instability involving a triathlon insert was reported.The event was not confirmed.During the revision surgery, the surgeon also reported discolouration of the device which was confirmed as consistent with absorption of synovial fluid through device inspection.Method & results -product evaluation and results: evaluation of the returned device indicated the following: damage consistent with explantation process was observed on the distal surface of the implant.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid; no evidence of discoloration consistent with oxidation was observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: not performed as no information was provided for review.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: evaluation of the returned device indicated the following: damage consistent with explantation process was observed on the distal surface of the implant.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration of the insert is consistent with absorption of synovial fluid; no evidence of discoloration consistent with oxidation was observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.With regards to the instability event, the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #6 13MM
• 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: 9191852
• Report Number: 0002249697-2019-03494
• Device Sequence Number: 16746488
• Product Code: MBH
• UDI-Device Identifier: 07613327045949
• UDI-Public: 07613327045949
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 12/13/2019

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 5531G613
• Device Lot Number: LGB731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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: 62 YR
• Patient Weight: 72