MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE

Model Number	01.32.156MH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 january 2022: lot 2004892: (b)(4) items manufactured and released on 15-oct-2020.Expiration date: 2025-10-04.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.Other devices involved: batch review performed on 27 january 2022.Liner: mpact 01.32.3248hcat hooded pe hc liner ø32/f (k132879) lot 1904363: (b)(4) items manufactured and released on 18-june-2019.Expiration date: 2024-06-03.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.Ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot 2006284: (b)(4) items manufactured and released on 21-sep-2020.Expiration date: 2025-09-10.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.Stem: masterloc 01.39.210 cementless ti coated lat stem # 10 (k151531) lot 166787b: (b)(4) items manufactured and released on 15-apr-2020.Expiration date: 2025-03-31.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.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot 2002401: (b)(4) items manufactured and released on 08-jun-2020.Expiration date: 2025-05-18.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.Screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot 2008456: (b)(4) items manufactured and released on 14-oct-2020.Expiration date: 2025-09-30.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
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer 11 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 january 2022: lot 2004892: (b)(4) items manufactured and released on 15-oct-2020.Expiration date: 2025-10-04.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.Other devices involved: batch review performed on 27 january 2022.Liner: mpact 01.32.3248hcat hooded pe hc liner ø32/f (k132879) lot 1904363: (b)(4) items manufactured and released on 18-june-2019.Expiration date: 2024-06-03.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.Ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot 2006284: (b)(4) items manufactured and released on 21-sep-2020.Expiration date: 2025-09-10.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.Stem: masterloc 01.39.210 cementless ti coated lat stem # 10 (k151531) lot 166787b: (b)(4) items manufactured and released on 15-apr-2020.Expiration date: 2025-03-31.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.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot 2002401: (b)(4) items manufactured and released on 08-jun-2020.Expiration date: 2025-05-18.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.Screws: mpact 01.32.6520 cancellous bone screw, flat head ø 6,5 l 20 (k103721) lot 2008456: (b)(4) items manufactured and released on 14-oct-2020.Expiration date: 2025-09-30.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
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer 11 months after primary.The surgery was completed successfully.

• Brand Name: CUP: MPACT 01.32.156MH ACETABULAR SHELL Ø56 MULTI-HOLE
• Common Device Name: 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: 13567346
• Report Number: 3005180920-2022-00134
• Device Sequence Number: 5848756
• Product Code: LPH
• UDI-Device Identifier: 07630030810862
• UDI-Public: 07630030810862
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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: 10/04/2025
• Device Model Number: 01.32.156MH
• Device Catalogue Number: 01.32.156MH
• Device Lot Number: 2004892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2020
• 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: Unknown