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

Model Number 01.12.33SN

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 march 2021.Lot 141072c: (b)(4) item manufactured and released on 28-aug-2019.Expiration date: 2024-07-29.No anomalies found related to the problem.

Event Description

The patient came in for primary hip surgery on (b)(6) 2021.During post-op recovery, the surgeon reviewed post-op x-rays that indicated the patient had too much offset.The surgeon decided to revise the stem and head on the same day of primary surgery.The surgery was completed successfully.Quadra h sn standard has been implanted.

Manufacturer Narrative

Batch review was corrected on 09-june-2021.Also device availability (section d9) has been corrected.Batch review performed on 09 june 2021.Lot 141072c: 1 item re-sterilized and released on 28-aug-2019.Expiration date: 2024-07-29.No anomalies found related to the problem.Note that lot 141072c is a re-sterilization of lot 141072.Lot 141072: 15 items manufactured and released on 10-apr-2014.Expiration date: 2025-07-20.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11654727
• MDR Text Key: 245073686
• Report Number: 3005180920-2021-00287
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802737
• UDI-Public: 07630030802737
• Combination Product (y/n): N
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 01.12.33SN
• Device Catalogue Number: 01.12.33SN
• Device Lot Number: 141072C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR