MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.21SN CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK; HIP CEMENTLESS STEM

Catalog Number	01.12.21SN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 july 2019: lot 187006: (b)(4) items manufactured and released on 22.11.2018.Expiration date: 2023-11-12.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: cup: mpact 01.32.154mb double mobility acetabular shell ø54 lot.188881 (k143453).Batch review performed on 29 july 2019: lot 188881: (b)(4) items manufactured and released on 13.03.2019.Expiration date: 2024-002-27.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.Liner: versafitcup dm 01.26.2854mhc double mobility hc liner 28/dmg lot.1810746 (k092265).Batch review performed on 29 july 2019: lot 1810746: (b)(4) items manufactured and released on 05.02.2019.Expiration date: 2024-01-21.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.Ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 lot.189636 (k112115).Batch review performed on 29 july 2019: lot 189636 : (b)(4) items manufactured and released on 21.02.2019.Expiration date: 2024-02-05.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
Second revision surgery performed after one month from the first revision due to an infection (the pathogen is unknown).The surgeon revised the head, stem, cup, and liner, and the surgery was completed successfully.During the first revision surgery also caused by infection, the stem, cup, and liner have been revised.

• Brand Name: STEM: QUADRA-H 01.12.21SN CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8878381
• Report Number: 3005180920-2019-00682
• Device Sequence Number: 11294634
• Product Code: JDI
• UDI-Device Identifier: 07630030802614
• UDI-Public: 07630030802614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• 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): 08/09/2019

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: 11/12/2023
• Device Catalogue Number: 01.12.21SN
• Device Lot Number: 187006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/09/2019
• 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