MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC Ø32/D; ACETABULAR LINER

Model Number	01.32.3241HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary hip surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the head and liner.Presently, on (b)(6) 2021, 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 19 november 2021: lot 2100154: (b)(4) items manufactured and released on 17-feb-2021.Expiration date: 2026-02-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Another devices involved: batch review performed on 19 november 2021: ball heads: mectacer 01.29.231h head biolox option ø 32 (k131518) lot 2006706: (b)(4) items manufactured and released on 21-oct-2020.Expiration date: 2025-09-24.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.Cup: mpact 01.32.150sh acetabular shell ø50 no-hole (k132879) lot 2012948: (b)(4) items manufactured and released on 01-apr-2021.Expiration date: 2026-03-21.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 01.39.009 cementless ti coated std stem size 9 (k151531) lot 166772a: (b)(4) items manufactured and released on 19-may-2020.Expiration date: 2025-04-27.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.Ball heads: mectacer 01.29.242a sleeve size l (k131518) lot 2006675: (b)(4) items manufactured and released on 30-oct-2020.Expiration date: 2025-09-24.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: LINER: MPACT FLAT PE HC Ø32/D
• Common Device Name: ACETABULAR LINER
• 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: 12867575
• Report Number: 3005180920-2021-00944
• Device Sequence Number: 3643834
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• 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): 11/24/2021

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: 02/01/2026
• Device Model Number: 01.32.3241HCT
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 2100154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2021
• 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 Sex: Male