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

Model Number	01.32.3239HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 february 2020: lot 1906064: (b)(4) items manufactured and released on 22-jul-2019.Expiration date: 2024-07-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional items involved in the event, batch review performed on 14 february 2020: screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 ((b)(4)) lot.1906576.Lot 1906576: (b)(4) items manufactured and released on 15-oct-2019.Expiration date: 2024-09-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Screws: mpact 01.32.6515 cancellous bone screw, flat head ø 6,5 l 15 ((b)(4)) lot.1902132 lot 1902132: (b)(4) items manufactured and released on 23-apr-2019.Expiration date: 2024-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Cup: mpact 01.32.148dh acetabular shell ø48 two-holes ((b)(4)) lot.1905333.Lot 1905333: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 ((b)(4)) lot.1905637.Lot 1905333: (b)(4) items manufactured and released on 20-sep-2019.Expiration date: 2024-09-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Stem: amistem p 01.18.429 amistem-p collared std stem size 00 ((b)(4)) lot.189965.Lot 189965: (b)(4) items manufactured and released on 06-feb-2019.Expiration date: 2024-01-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other 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 an i&d and removed all components from the patient and then put brand new clean implants in the patient 12 days after primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø32/C
• Common Device Name: FALT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9804583
• Report Number: 3005180920-2020-00137
• Device Sequence Number: 10957084
• Product Code: LPH
• UDI-Device Identifier: 07630030811845
• UDI-Public: 07630030811845
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 07/01/2024
• Device Model Number: 01.32.3239HCT
• Device Catalogue Number: 01.32.3239HCT
• Device Lot Number: 1906064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/09/2020
• 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: 69 YR