MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.34SN CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK; STEM CEMENTLESS

Model Number	01.12.34SN
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 march 2022.Lot 093004: (b)(4) items manufactured and released on 22-mar-2010.Expiration date: 2015-feb-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event since 2018.
Event or Problem Description
The patient came in reporting pain due to a periprosthetic fracture that was caused from falling.About 9 years and 10 months after the primary surgery, the surgeon cabled the fracture and revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H 01.12.34SN CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK
• Common Device Name: STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14040033
• Report Number: 3005180920-2022-00232
• Device Sequence Number: 20408492
• Product Code: LZO
• UDI-Device Identifier: 07630030802744
• UDI-Public: 07630030802744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 02/28/2015
• Device Model Number: 01.12.34SN
• Device Catalogue Number: 01.12.34SN
• Device Lot Number: 093004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2010
• 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: Required Intervention
• Patient Sex: Male