MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES; CEMENTLESS ACETABULAR CUP

Model Number	01.32.156DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 january 2022.Lot 2009438: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-30.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 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.2013105.Batch review performed on 26 january 2022.Lot 2013105: (b)(4) items manufactured and released on 13-jan-2021.Expiration date: 2026-01-03.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: stem: amistem p 01.18.403 amistem-p std stem size 3 (k173794) lot.2011357.Batch review performed on 26 january 2022.Lot 2011357: (b)(4) items manufactured and released on 27-jan-2021.Expiration date: 2026-01-18.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 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2011678.Batch review performed on 26 january 2022.Lot 2011678: (b)(4) items manufactured and released on 22-feb-2021.Expiration date: 2026-02-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At about 6 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 january 2022.Lot 2009438: (b)(4) items manufactured and released on 10-dec-2020.Expiration date: 2025-11-30.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: impact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.2013105.Batch review performed on 26 january 2022.Lot 2013105: (b)(4) items manufactured and released on 13-jan-2021.Expiration date: 2026-01-03.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: stem: amistem p 01.18.403 amistem-p std stem size 3 (k173794) lot.2011357.Batch review performed on 26 january 2022.Lot 2011357: (b)(4) items manufactured and released on 27-jan-2021.Expiration date: 2026-01-18.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 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2011678.Batch review performed on 26 january 2022.Lot 2011678: (b)(4) items manufactured and released on 22-feb-2021.Expiration date: 2026-02-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At about 6 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR CUP
• 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: 13469160
• Report Number: 3005180920-2022-00085
• Device Sequence Number: 17134578
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/07/2022

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: 11/30/2025
• Device Model Number: 01.32.156DH
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 2009438
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2020
• 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 Sex: Male