MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK; CEMENTLESS HIP STEM

Model Number	01.12.31SN
Medical Device Problem Code	Osseointegration Problem (3003)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 february 2022: lot 082700: 25 items manufactured and released on 11-nov-2008.Expiration date: 2013-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2018.
Event or Problem Description
At 13 years 1 month after the primary, the patient came in reporting pain due to a loose stem and the cause of the loose stem is unknown.The surgeon revised the stem and head with competitor components.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• 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: 13768694
• Report Number: 3005180920-2022-00171
• Device Sequence Number: 3837073
• Product Code: JDI
• UDI-Device Identifier: 07630030802713
• UDI-Public: 07630030802713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

1 Device 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: 09/30/2013
• Device Model Number: 01.12.31SN
• Device Catalogue Number: 01.12.31SN
• Device Lot Number: 082700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2008
• 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