MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; HIP IMPLANT: CEMENTLESS, HA COATED STEM

Model Number	01.12.23SN
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 february 2020: lot 185839: (b)(4) items manufactured and released on 05-nov-2018.Expiration date: 2023-10-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medicla affirs director: fracture with consequent subsidence and stem substitution in a primary cementless tha few days after initial surgery.No reason to suspect a faulty device.Visual inspection performed by medacta r&d department: implant with minimal signs of extraction on the neck, head base and stem.Ha coating fully intact.
Event or Problem Description
Revision surgery about 20 days after primary for stem subsidence.The reason is unknown.Fracture at lesser trochanter region detected during revision.The surgeon revised successfully the stem and the ceramic ball head.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: HIP IMPLANT: CEMENTLESS, HA COATED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9738044
• Report Number: 3005180920-2020-00076
• Device Sequence Number: 1815258
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 10/23/2023
• Device Model Number: 01.12.23SN
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 185839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/21/2020
• 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
• Patient Weight: 103