MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES; HIP ACETABULAR SHELL

Model Number	01.32.152DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2021.Lot 2105760: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 2026-08-16.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 items involved in the event, batch review performed on 17 december 2021.Liner: mpact 01.32.3644hcat hooded pe hc liner ø36/e lot.2006616.Lot 2006616: (b)(4) items manufactured and released on 22-sep-2020.Expiration date: 2025-09-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Stem: quadra-c 01.12.041 cemented, mirror polishing std stem size 1 12/14 lot.2106155.Lot 2106155: (b)(4) items manufactured and released on 22-july-2021.Expiration date: 2026-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 lot.2011671 lot 2011671: (b)(4) items manufactured and released on 02-march-2021.Expiration date: 2026-02-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.
Event or Problem Description
At 1 month after the primary, hip surgery was performed due to infection.The surgeon revised all the components.
Event or Problem Description
On (b)(6) 2022: spacer implants were revised and permanent devices implanted.
Additional Manufacturer Narrative
On (b)(6) 2022: spacer implants were revised and permanent devices implanted.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
• Common Device Name: HIP 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: 13058749
• Report Number: 3005180920-2021-01033
• Device Sequence Number: 17115660
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 08/16/2026
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 2105760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2021
• 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 Age: 62 YR
• Patient Sex: Female