MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL 52 TWO-HOLES; HIP UNCEMENTED SHELL

Model Number	01.32.152DH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2020: lot 184592: (b)(4) items manufactured and released on 17-oct-2018.Expiration date: 2023-10-08.No anomalies found related to the problem.To date, 98 items of the same lot have been already sold without any similar reported event.Additional device involved: batch review performed on (b)(6) 2020: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot 185987: (b)(4) items manufactured and released on 25-sep-2018.Expiration date: 2023-09-10.No anomalies found related to the problem.To date, 108 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed, 1 day after primary surgery, due to dissociation of the liner from the cup.Right side.

• Brand Name: MPACT ACETABULAR SHELL 52 TWO-HOLES
• Common Device Name: HIP UNCEMENTED SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10613014
• Report Number: 3005180920-2020-00661
• Device Sequence Number: 3735187
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• 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): 10/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2023
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 184592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• 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: 78 YR
• Patient Weight: 81