MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5532-G-311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding patient factors involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: materials reviewed: 04/19/2021: stryker pi report.03/10/2021: x-ray series ap/lat sunrise (only sunrise labeled as right).Cemented ps triathlon with universal baseplate, no gross abn.Small amount of cement posteriorly, slight overhang of tibia laterally, small bony fragment/loose body lateral patella.(b)(6) 2018: implant sheet, right knee.Triathlon x3 asymmetric patella a29-9mm, size #3 universal tibia baseplate, size #2 ps right femoral component, !!mm ps poly size #3, 2 bags palacos r cement.Event confirmation: the event cannot be confirmed.There was placement of a cemented tka (b)(6) 2018.X-rays show the knee in stable position and stable fixation on 03/10/2021.There was no documentation or records outlining an infection or an effusion or a revision surgery.Root cause: a root cause may not be attributed to the case without review of additional medical records that outline the case and surgical history and findings.Product 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 lot referenced.Conclusions: 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 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.Catalog numbers and lot codes of other devices listed in this report: 5551-g-299 triathlon asymmetric x3 patella lot 7hlx.5521-b-300 tri ts baseplate size 3 lot bvv9aa.5515f202 triathlon ps fem comp #2r-cem lot c676n.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
As reported: "right knee explantation with placement of antibiotic spacer.Pre-op diagnosis: pain due to rtk replacement, subsequent encounter knee effusion, right.No further information available per hospital." rep provided a primary usage sheet and x-rays.

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 11816923
• Report Number: 0002249697-2021-00842
• Device Sequence Number: 14401095
• Product Code: MBH
• UDI-Device Identifier: 07613327050639
• UDI-Public: 07613327050639
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2021

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: 04/30/2023
• Device Model Number: 5532-G-311
• Device Catalogue Number: 5532-G-311
• Device Lot Number: 85409018A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/13/2021
• 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: 76 YR
• Patient Weight: 61