MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM CONVERTER LINER E/DMC; HIP LINER DM

Catalog Number	01.32.3844MC
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-oct-2019: lot 132999c: (b)(4) items manufactured and released on 28-aug-2018.Expiration date: 2023-07-26.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.Another device was involved in the event: liner: mpact dm 01.26.2246mhc double mobility hc liner 22.2/dmc lot.178325 (k092265).Batch review performed on 15-oct-2019: lot 178325: (b)(4) items manufactured and released on 21-mar-2018.Expiration date: 2023-03-06.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 for primary hip surgery and was implanted with competitor items.The date of the primary hip surgery is unknown.Subsequently, on (b)(6) 2019, the patient came in complaining of pain and the cause of the pain was unknown.Medacta products implanted.The surgery was completed successfully.Presently, on (b)(6) 2019 (1 month after the primary), the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.

• Brand Name: LINER: MPACT DM CONVERTER LINER E/DMC
• Common Device Name: HIP LINER DM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9195805
• Report Number: 3005180920-2019-00870
• Device Sequence Number: 19480289
• Product Code: LZO
• UDI-Device Identifier: 07630030812200
• UDI-Public: 07630030812200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131458
• 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): 10/16/2019

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: 07/26/2023
• Device Catalogue Number: 01.32.3844MC
• Device Lot Number: 132999C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/16/2019
• 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