MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G316
Medical Device Problem Codes	Fracture (1260); Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/01/2016
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 reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Surgeon revised due to instability.Implant retrieval noted fracture posterior edge of insert.
Additional Manufacturer Narrative
An event regarding joint instability and crack/fracture involving a triathlon insert was reported.The event of crack/fracture was not confirmed however wear/damage was confirmed through the provided picture.The event of instability was not confirmed.Method & results: -product evaluation and results: the reported device was not returned however a picture of the explanted insert was provided in the implant retrieval report.The photo was not very clear but the posterior edge of insert appears to be worn off.-medical records received and evaluation: not performed as the op record is illegible.-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 exact cause of the event could not be determined because insufficient information was provided.Further information such as evaluation of the returned device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be re-opened.
Event or Problem Description
Surgeon revised due to instability.Implant retrieval noted fracture posterior edge of insert.

• Brand Name: X3 TRIATHLON CS INSERT #3 16MM
• 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: 8373445
• Report Number: 0002249697-2019-01196
• Device Sequence Number: 16588034
• Product Code: MBH
• UDI-Device Identifier: 07613327045758
• UDI-Public: 07613327045758
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 5531G316
• Device Lot Number: LDP406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 10/09/2019
• 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: 71 YR