MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES; ACETABULAR CUP

Model Number	01.32.150DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 november 2020: lot 1908320: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-12-02.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.Additional implant involved: ball heads: mectacer 01.29.231h head biolox option ø 32 (k131518) lot.170727.Batch review performed on 28 november 2020: lot 170727: (b)(4) items manufactured and released on 24-aug-2017.Expiration date: 2022-08-15.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.Additional implant involved: ball heads: mectacer 01.29.241a sleeve size m (k131518) lot.187108: batch review performed on 28 november 2020: lot 187108: (b)(4) items manufactured and released on 12-dec-2018.Expiration date: 2023-11-27.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.Additional implant involved: liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot.1908277.Batch review performed on 28 november 2020: lot 1908277: (b)(4) items manufactured and released on 18-oct-2019.Expiration date: 2024-10-05.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.Additional implant involved: screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot.157802.Batch review performed on 28 november 2020: lot 157802:(b)(4) items manufactured and released on 03-mar-2016.Expiration date: 2021-02-20.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.Additional implant involved: screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot.161076.Batch review performed on 28 november 2020: lot 161076: (b)(4) items manufactured and released on 02-may-2016.Expiration date: 2021-04-19.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.Additional implant involved: stem: quadra-h 01.12.22sn cementless, ha coated std stem size 2, short neck (k082792) lot.188790.Batch review performed on 18 december 2020: lot 188790: (b)(4) items manufactured and released on 31-jan-2019.Expiration date: 2024-01-20.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.
Event or Problem Description
22 days after primary surgery, the patient was diagnosed with infection and all the implants have been removed.A cement spacer was implanted.

• Brand Name: CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11047211
• Report Number: 3005180920-2020-00934
• Device Sequence Number: 2692444
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• 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: 2020
• 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): 12/21/2020

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: Health Professional
• Device Expiration Date: 12/02/2024
• Device Model Number: 01.32.150DH
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 1908320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/21/2020
• 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: 51 YR