MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50; HIP DOUBLE MOBILITY ACETABULAR SHELL

Model Number 01.32.150MB

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27-jun-2022.Lot 1901388: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Other devices involved: batch review performed on 08-jun-2022.Liner: versafitcup dm 01.26.2850mhc double mobility hc liner 28/dme (k092265) lot 182645: (b)(4) items manufactured and released on 26-jul-2018.Expiration date: 2023-07-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

Event Description

The patient had a primary hip surgery on (b)(6) 2020.On (b)(6) 2021, the patient came in reporting pain due to a leg length discrepancy.The surgeon revised the head and liner.On (b)(6) 2022, the patient came in reporting instability and looseness of the joint, the cause is unknown.The stem was solid and well fixed, so the surgeon revised the cup and liner with competitor components and revise the head with a medacta head.The surgery was completed successfully.

• Brand Name: CUP: MPACT 01.32.150MB DOUBLE MOBILITY ACETABULAR SHELL Ø50
• Type of Device: HIP DOUBLE MOBILITY 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: 14883686
• MDR Text Key: 295110483
• Report Number: 3005180920-2022-00496
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• 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: 07/01/2022

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: 01.32.150MB
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 1901388
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2019
• 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): Required Intervention
• Patient Sex: Female