MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø54

Catalog Number 01.32.154MB

Device Problem Device Slipped (1584)

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

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 14 may 2019: lot 188881: (b)(4) items manufactured and released on 13-mar-2019.Expiration date: 2024-02-27.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

During the primary hip surgery and after implanting the 54mm mpact dm cup, the cup disengaged and spun out while the hip was taken through range of motion.The surgeon re-implanted the cup and it disengaged and spun out again.The surgeon chose to implant a 54mm mpact two hole cup and 2 mpact dome screws for better fixation and the cup was stable through range of motion.Trials were inserted and the hip was taken through range of motion.The trials were removed and permanent implants were implanted.The surgeon was unable to reduce the hip after multiple attempts and decided to remove the 36mm biolox delta head l.A 36mm biolox delta head m was implanted and the surgeon was able to reduce the hip.The surgery was completed successfully removing all components except for the stem.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø54
• 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: 8615718
• MDR Text Key: 145382583
• Report Number: 3005180920-2019-00394
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860980
• UDI-Public: 07630030860980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143453
• 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: 05/16/2019

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 Expiration Date: 02/27/2024
• Device Catalogue Number: 01.32.154MB
• Device Lot Number: 188881
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2019
• 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