MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; HIP STEM CEMENTLESS

Model Number 01.12.035

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Event Description

During surgery a quadra-h size 5 (ref.01.12.035, lot 152232b) was opened and in the package there was a quadra-s size 5 (ref.01.12.015, lot 101086a).A back-up quadra-h was used to complete the surgery.

Manufacturer Narrative

Batch review performed on 23.Jun.2022.Lot 152232b: (b)(4).Expiration date: 2025-08-18.No anomalies found related to the problem.The other device involved in the mix-up: stem: quadra-s 01.12.015 cementless, sand blasted lat stem size 5 (k072857) lot 101086a: (b)(4).Expiration date: 2025-08-18.No anomalies found related to the problem.Analysis results: the mix-up has been confirmed; a box labeled with the ref.H 01.12.035 (lot 152232b, cementless, ha coated lat stem size 5) was found to include ref.01.12.015 (lot 101086a, quadra-s cementless, sand blasted lat stem size 5) and vice-versa.The letters "a" or "b" are present at the end of the lot numbers because they are assigned during the re-sterilization processing of the lots, as per medacta international internal procedures.Both lots involved in the action are composed of 1 device each.The corresponding item labeled as ref.01.12.015, lot 101086a, has been located and quarantined.It was under warehouse control and had not been distributed to a hospital.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Type of Device: HIP STEM CEMENTLESS
• 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: 14797399
• MDR Text Key: 300635599
• Report Number: 3005180920-2022-00488
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 152232B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White