MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER 32/D; ACETABULAR LINER PE HC

Model Number	01.32.3241HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2020: lot 120305: (b)(4) items manufactured and released on 28-feb-2012.Expiration date: 2017-01-31.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 since 2016.Additional implant involved: ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot.160547.Batch review performed on 18 november 2020: lot 160547: (b)(4) items manufactured and released on 29-apr-2016.Expiration date: 2021-04-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Event or Problem Description
The patient came in, 4 years and 4 months after primary surgery, due to signs of an infection and the pathogen is unknown.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER 32/D
• Common Device Name: ACETABULAR LINER PE HC
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10920070
• Report Number: 3005180920-2020-00873
• Device Sequence Number: 16805463
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• 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: 2016
• Device Explanted Year: 2020
• 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): 11/30/2020

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: 01/31/2017
• Device Model Number: 01.32.3241HCT
• Device Catalogue Number: 01.32.3241HCT
• Device Lot Number: 120305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2020
• Initial Report FDA Received Date: 11/30/2020
• 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