MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #2 CR INSERT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5530-P-209
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	01/11/2021
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's left knee was revised due to instability and pain.A cr femur and insert were revised to a ts femur, ps insert, cemented stem and augments.Rep provided primary and revision usage and a picture of the explanted liner, and confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised due to instability and pain.A cr femur and insert were revised to a ts femur, ps insert, cemented stem and augments.Rep provided primary and revision usage and a picture of the explanted liner, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding instability and crack/fracture involving a triathlon insert was reported.The event was confirmed for crack/fracture while instability is not confirmed.Method & results: product evaluation and results: material analysis, functional and dimensional inspections could not be performed as the device was not returned.Visual inspection - the reported device was not returned however photographs were provided for review.The photographs show a recently explanted device with broken edge.This explanted picture confirms crack/fracture of device.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 patient was revised due to pain, crack/fracture and instability.The event was confirmed for crack/fracture while instability is not confirmed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the 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 reopened.H3 other text : device not available.

• Brand Name: TRIATHLON #2 CR INSERT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11264628
• Report Number: 0002249697-2021-00187
• Device Sequence Number: 13744903
• Product Code: JWH
• UDI-Device Identifier: 07613327041675
• UDI-Public: 07613327041675
• 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: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 05/31/2018
• Device Model Number: 5530-P-209
• Device Catalogue Number: 5530P209
• Device Lot Number: LDI066
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/02/2021
• 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: 72 YR