MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number	5531G311
Medical Device Problem Codes	Break (1069); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/05/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised due to instability.Intra-operatively, the 3 x 11 cs insert was observed to be broken posteriorly on the medial and lateral aspect of the device.The insert was revised.The revised device will be returned and the rep provided 1 page of the primary operative report, and reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's right knee was revised due to instability.Intra-operatively, the 3x11 cs insert was observed to be broken posteriorly on the medial and lateral aspect of the device.The insert was revised.The revised device will be returned and the rep provided 1 page of the primary operative report, and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding instability and wear involving a triathlon insert was reported.The event of instability was not confirmed but the failure mode of wear was confirmed based on evaluation of the returned device.Method & results product evaluation and results: the damage present on the articulating surface of the insert was consistent with delamination from articulation against the femoral component.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.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: cannot confirm event, need additional information; complete primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.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: the evaluation of the returned device indicated that the damage present on the articulating surface of the insert was consistent with delamination from articulation against the femoral component.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.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such ascomplete primary and revision operative reports, clinical and past medical history and additional serial dated x-rays 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 #3 11MM
• 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: 9141866
• Report Number: 0002249697-2019-03354
• Device Sequence Number: 13909691
• Product Code: MBH
• UDI-Device Identifier: 07613327045734
• UDI-Public: 07613327045734
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 11/27/2019

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: 10/31/2015
• Device Catalogue Number: 5531G311
• Device Lot Number: LCB455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/27/2019
• 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