MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #5L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-501
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.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.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.A size 5 tritanium tibial component, size 5cr femoral component, and insert were revised to a size 5 universal baseplate, size 5ps femoral component, and insert.Surgeon's opinion was that the tibial component was implanted with too much varus.There are no allegations against the insert.Femoral component was revised to increase knee rotation, but otherwise there are no allegations against the femoral component.
Additional Manufacturer Narrative
An event regarding malposition involving triathlon femoral component was reported.  conclusion:  based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.Since surgeon's opinion was that the tibial component was implanted with too much varus.There are no allegations against the femoral component.No further investigation is required at this time.A full investigation is completed on triathlon baseplate within the same pi.  if additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain.A size 5 tritanium tibial component, size 5cr femoral component, and insert were revised to a size 5 universal baseplate, size 5ps femoral component, and insert.Surgeon's opinion was that the tibial component was implanted with too much varus.There are no allegations against the insert.Femoral component was revised to increase knee rotation, but otherwise there are no allegations against the femoral component.

• Brand Name: TRIATHLON P/A CR BEADED #5L
• 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: 11730572
• Report Number: 0002249697-2021-00739
• Device Sequence Number: 14280061
• Product Code: MBH
• UDI-Device Identifier: 07613327040982
• UDI-Public: 07613327040982
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/18/2021

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: 10/31/2025
• Device Model Number: 5517-F-501
• Device Catalogue Number: 5517F501
• Device Lot Number: LCL6T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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: 54 YR
• Patient Weight: 100