MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL 52

Model Number	01.32.152MB
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-sep-2021: lot 1909301: (b)(4) items manufactured and released on 09-mar-2021.Expiration date: 2025-02-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other devices involved: batch review performed on 14-sep-2021: liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot 182236: (b)(4) items manufactured and released on 04-jul-2018.Expiration date: 2023-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient sent an e-mail to medacta reporting the details of the revision surgery 1 year and 1 month after the primary and a complaint has been notified.The surgeon found notable metallosis in the synovium and inflammation due to impaction of the metallic titanium femoral neck against the edge of the cup.There was a notch that had been bored into the femoral neck because of this prosthetic impingement.

• Brand Name: CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12474807
• Report Number: 3005180920-2021-00736
• Device Sequence Number: 3939467
• Product Code: LPH
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• 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: 2021
• 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): 08/16/2021

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: 02/25/2025
• Device Model Number: 01.32.152MB
• Device Catalogue Number: 01.32.152MB
• Device Lot Number: 1909301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention