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

Model Number	01.12.24SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 february 2020: lot 155687: (b)(4) items manufactured and released on 04-apr-2016.Expiration date: 2021-03-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medacta medical affairs director: shortly after revision of the femoral head due to stem subsidence barely 1 year postoperatively, the patient reported persistent pain.Images provided show the presence of a loosened stem.No information concerning patient general health status and activity level is available.Aseptic loosening is a possible literature described adverse event and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery after 2 years and 9 months from the primary due to mid -distal loosening of the hip stem.The surgeon revised the stem.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9805217
• Report Number: 3005180920-2020-00147
• Device Sequence Number: 16338208
• Product Code: LZO
• UDI-Device Identifier: 07630030802645
• UDI-Public: 07630030802645
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 03/09/2020

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: 03/17/2021
• Device Model Number: 01.12.24SN
• Device Catalogue Number: 01.12.24SN
• Device Lot Number: 155687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/09/2020
• 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 Age: 64 YR