MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK; UNCEMENTED HIP STEM

Catalog Number	01.12.32SN
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2019: lot 1901703: 16 items manufactured and released on 29-may-2019.Expiration date: 2024-05-20.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in complaining of pain due to a fracture distal to the tip of the stem.The cause of the fracture is unknown.The surgeon cabled the fracture and revised the medacta head and stem with competitor items 3 weeks after primary.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9283650
• Report Number: 3005180920-2019-00939
• Device Sequence Number: 2310822
• Product Code: JDI
• UDI-Device Identifier: 07630030802720
• UDI-Public: 07630030802720
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2019

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: 05/20/2024
• Device Catalogue Number: 01.12.32SN
• Device Lot Number: 1901703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/06/2019
• 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 Age: 79 YR