MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 48 TWO-HOLES; CEMENTLESS ACETABULAR CUP

Model Number	01.32.148DH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14.Apr.2021: lot 1900178: (b)(4) items manufactured and released on 10-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: liner: mpact 01.32.3239hcat hooded pe hc liner ø32/c (k132879) lot.188518.Batch review performed on 14.Apr.2021: lot 188518: (b)(4) items manufactured and released on 7-dec-2018.Expiration date: 2023-11-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.1909754.Batch review performed on 14.Apr.2021: lot 1909754: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event.
Event or Problem Description
7 months after the primary surgery the cup, liner, ball head and screws were revised due to recurrent dislocations(head from the liner) and malpositioned cup(it was too retroverted) what may have contributed to the dislocations.

• Brand Name: CUP: MPACT ACETABULAR SHELL 48 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11775803
• Report Number: 3005180920-2021-00362
• Device Sequence Number: 17055643
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• 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): 05/05/2021

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: 04/30/2024
• Device Model Number: 01.32.148DH
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 1900178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/05/2021
• 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
• Patient Age: 69 YR