MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4; TIBIAL TRAY FIXED CEMENTED

Model Number	01.12.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 april 2021: lot 081304: (b)(4) items manufactured and released on 23-jun-2008.Expiration date: 2013-04-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event clinical evaluation performed by medical affairs director: 13 years after primary cementless tha the stem fractures and needs substitution.The medacta stem had originally been coupled with a large diameter metal-on-metal head by a different manufacturer.Severe wear of the stem titanium spigot is visible, almost certainly caused by fretting against the cobalt socket of the head during the years.The two components were not designed to be coupled together and this may have contributed to the catastrophic evolution.Metal particles generated by metal-on-metal tribology may also have slipped between head and stem taper and accelerated the wear process.The root cause is probably unforeseen coupling of head and stem.Preliminary investigation performed by r&d project manager: looking at the images received of the complaint it is visible that the stem neck is broken in the middle part.No particular signs or damages are visible.The images have poor quality and not zoomed.It is not possible to see details of the fractured area.
Event or Problem Description
The patient came in reporting pain.The surgeon observed that the neck of the stem had broken.The surgeon revised the medacta stem, and competitor head, cup, and liner to competitor components 12 years and 4 months after primary.The surgery was completed successfully.The primary surgery in 2008 was a medacta stem coupled with a competitor's metal on metal shell and head.The patient did not undergo previous revision surgery.

• Brand Name: STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 4
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11782830
• Report Number: 3005180920-2021-00363
• Device Sequence Number: 3659845
• Product Code: JDI
• UDI-Device Identifier: 07630030801853
• UDI-Public: 07630030801853
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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: 04/30/2013
• Device Model Number: 01.12.004
• Device Catalogue Number: 01.12.004
• Device Lot Number: 081304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/06/2021
• 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: Required Intervention