MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø50 TWO-HOLES; HIP CEMENTLESS SHELL

Model Number	01.32.150DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the cup, liner head, and stem almost 2 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 21 january 2022: lot 2104109: (b)(4) items manufactured and released on 07-jun-2021.Expiration date: 2026-05-19.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 devices involved.Batch reviews performed on 21 january 2022.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot 2006532: (b)(4) items manufactured and released on 25-aug-2020.Expiration date: 2025-08-17.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: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot 2012913: (b)(4) items manufactured and released on 12-apr-2021.Expiration date: 2026-03-26.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: amistem-p collared 01.18.431 amistem-p collared std stem size 1 (k173794) lot 2011561: (b)(4) items manufactured and released on 01-feb-2021.Expiration date: 2026-01-20.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.

• Brand Name: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• Common Device Name: HIP CEMENTLESS 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: 13356854
• Report Number: 3005180920-2022-00039
• Device Sequence Number: 11207294
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• 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: 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): 01/26/2022

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: 05/19/2026
• Device Model Number: 01.32.150DH
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 2104109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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: 61 YR
• Patient Sex: Female