MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH NO 2 TRIATH TS PLUS TIB INS X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5537-G-211-E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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
On 5/9, i was in a total knee.This case was a mako case.The implants we cut for were a size 2 right ps femur and a size 3 universal baseplate.I picked up the stryker implants and read them and at the same time showed the doctor.He agreed with the implants and said it was ok to open them.I read a size 2 right ps femur, 3 universal baseplate, 32 asymmetric patella and a 2x11 ts poly, and expirations for all implants.I opened the outer packaging and handed the implants to the nurse who then again read out the sizes as she dropped them on the back table for the scrub tech to assemble.We went through implanting and doctor said the knee felt great through the full rom.I then sent the billing.Billing called me a few hours later and asked if i had made a mistake and put a 2x11 ts poly in on accident or if it was a 3x11 ts poly.I went back and looked at the billing and saw this error.From that point billing contacted doctor and told him the situation and made him aware of it.Doctor later on in the day, after that phone call decided he was going to go back and revise the knee to put in the proper poly size (3x11 ts poly).The revision took place the morning of 5/11 where billing was present for that case.

• Brand Name: NO 2 TRIATH TS PLUS TIB INS X3 POLY 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19629176
• Report Number: 0002249697-2024-00924
• Device Sequence Number: 20599355
• Product Code: MBH
• UDI-Device Identifier: 07613327287929
• UDI-Public: 07613327287929
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: 02/28/2025
• Device Catalogue Number: 5537-G-211-E
• Device Lot Number: K46JPY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female