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

Catalog Number	01.32.3241HCAT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2019: lot 172563: 30 items manufactured and released on (b)(6) 2017.Expiration date: 2022-10-26.No anomalies found related to the problem.To date, 21 items of the same lot have been already sold without any other similar reported event.Batch reviews performed on (b)(6) 2019.Stem: quadra-h 01.12.20sn cementless, ha coated std stem size 0, short neck (k082792) lot 189854: 77 items manufactured and released on 07-feb-2019.Expiration date: 2024-01-14.No anomalies found related to the problem.To date, 43 items of the same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 177687: 237 items manufactured and released on 09-apr-2018.Expiration date: 2023-03-23.No anomalies found related to the problem.To date, 220 items of the same lot have been already sold without any other 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 an i&d and poly-swap 1 month and 5 days after primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT HOODED PE HC LINER Ø32/D
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9222731
• Report Number: 3005180920-2019-00892
• Device Sequence Number: 13844073
• Product Code: LPH
• UDI-Device Identifier: 07630030811869
• UDI-Public: 07630030811869
• Combination Product (Y/N): N
• 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): 10/23/2019

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: 10/26/2022
• Device Catalogue Number: 01.32.3241HCAT
• Device Lot Number: 172563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/23/2019
• 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