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

Catalog Number	01.32.3239HCAT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 june 2019: lot 184756: (b)(4) items manufactured and released on 06-sep-2018.Expiration date: 2023-08-26.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.Another implant was involved in the complaint.Batch review performed on 11 june 2019: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 lot.187079 (k112115): (b)(4) items manufactured and released on 12-dec-2018.Expiration date: 2023-11-27.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 infection 1 month after primary, the pathogen is unknown.The surgeon performed a washout and revised the head and liner.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø32/C
• Common Device Name: HIP PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8739710
• Report Number: 3005180920-2019-00521
• Device Sequence Number: 14086963
• Product Code: LPH
• UDI-Device Identifier: 07630030811838
• UDI-Public: 07630030811838
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• 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): 06/27/2019

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: 08/26/2023
• Device Catalogue Number: 01.32.3239HCAT
• Device Lot Number: 184756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/27/2019
• 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