MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES

Catalog Number 01.32.152DH

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 13 september 2019: lot 1900180: (b)(4) items manufactured and released on 23.May.2019.Expiration date: 2024-05-12.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.

Event Description

Surgeon was performing amis surgery, had implanted cup and liner, cemented in stem and was final trialing (the only trial component in the final trial was the trial head, all others were already implanted) the head when he noticed the cup had rotated.The stem and cup, liner and screw have been revised.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
• Type of Device: ACETABULAR SHELL
• 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: 9138848
• MDR Text Key: 195100338
• Report Number: 3005180920-2019-00824
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132879
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 1900180
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2019
• 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: 87 YR