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
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00496
• Device Sequence Number: 17403293
• Product Code: LPH
• UDI-Device Identifier: 07630030860966
• UDI-Public: 07630030860966
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2024
• Device Model Number: 01.32.150MB
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 1901388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female