MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL 54 MULTI-HOLE

Model Number	01.32.154MH
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 august 2020: lot 1811207: (b)(4) items manufactured and released on 08-apr-2019.Expiration date: 2024-03-28.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.Clinical evaluation: few weeks after primary hybrid tha the cup must be retrieved because it is painful.From the images received, the cup appears to be distant from the acetabular bottom, with suboptimal orientation.A cement mantle fracture is also visible distal to the stem, almost certainly irrelevant at this stage.We cannot comment on the possible causes of acetabular position, but there is no reason to suspect that it can be due to a defect of the device.
Event or Problem Description
Revision surgery performed due to a gap between cup and acetabulum, 3 months after the primary surgery.Primary surgery was performed on (b)(6) 2020, the patient came to the hospital reporting pain on (b)(6).

• Brand Name: MPACT ACETABULAR SHELL 54 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10389663
• Report Number: 3005180920-2020-00505
• Device Sequence Number: 19397977
• Product Code: LPH
• UDI-Device Identifier: 07630030810831
• UDI-Public: 07630030810831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2020

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: No Information
• Device Expiration Date: 03/28/2024
• Device Model Number: 01.32.154MH
• Device Catalogue Number: 01.32.154MH
• Device Lot Number: 1811207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2020
• Initial Report FDA Received Date: 08/11/2020
• 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
• Patient Age: 73 YR