MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG; HIP HC LINER

Catalog Number	01.26.2854MHC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 august 2019: lot 1810747: (b)(4) items manufactured and released on 13-feb-2019.Expiration date: 2024-01-19.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 implants involved in the event, batch review performed on 28 august 2019: ball heads: mectacer 01.29.230h head biolox option ø 28 (k131518) lot.189669.Lot 189669: (b)(4) items manufactured and released on 03-jan-2019.Expiration date: 2024-01-21.No anomalies found related to the problem.To date, items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.243a sleeve size xl (k131518) lot.1810821 lot 1810821: (b)(4) items manufactured and released on 06-mar-2019.Expiration date: 2024-02-24.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.Stem: masterloc 01.39.408 cementless ti coated lat plus stem size 8 (k173267) lot.181502.Lot 181502: (b)(4) items manufactured and released on 05-jun-2018.Expiration date: 2023-05-24.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 01.32.154mb double mobility acetabular shell ø54 (k143453) lot.1900194.Lot 1900194: (b)(4) items manufactured and released on 13-jun-2019.Expiration date: 2024-05-29.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 had a primary hip surgery on (b)(6) 2019.The patient subsequently came in on (b)(6) 2019 due to signs of an infection.The pathogen was unknown and the surgeon (md craig bone) revised the head, sleeve and poly, complaint (b)(4) [mdr 2019-00757] was filled.On the (b)(6) 2019 about 1 month after primary the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and implanted an antibiotic spacer.The surgery was completed successfully.The surgeon plans to implant permanent hardware in 6 weeks.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMG
• Common Device Name: HIP HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9085573
• Report Number: 3005180920-2019-00771
• Device Sequence Number: 17040825
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 01/19/2024
• Device Catalogue Number: 01.26.2854MHC
• Device Lot Number: 1810747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/19/2019
• 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