MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 36/G; HIP FLAT PE HC LINER

Model Number	01.32.3652HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2021: lot 2003336: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 2025-06-29.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 item involved in the event, batch review performed on 02 september 2021.Cup: mpact 3dmetal 01.38.060dh acetabular shell ø60 two-hole (k171966) lot.2010341.Lot 2010341: (b)(4) items manufactured and released on 25-feb-2021.Expiration date: 2026-02-15.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 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2009406.Lot 2009406: (b)(4) items manufactured and released on 21-jan-2021.Expiration date: 2026-01-12.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.Stem: sms solid 01.36.051 sms solid stem std size 11 (k181693) lot.2004949.Lot 2004949: (b)(4) items manufactured and released on 21-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.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.2010033.Lot 2010033: (b)(4) items manufactured and released on 09-nov-2020.Expiration date: 2025-10-29.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 hardware, and implanted new hardware 2 months after primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 36/G
• Common Device Name: HIP FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12433068
• Report Number: 3005180920-2021-00708
• Device Sequence Number: 3308739
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 06/29/2025
• Device Model Number: 01.32.3652HCT
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 2003336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/07/2021
• 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