MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK; HIP CEMENTLESS STEM

Catalog Number	01.12.20SN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 july 2019: lot 187005: (b)(4) items manufactured and released on 22-nov-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- ball heads: mectacer 01.29.203 biolox delta ceramic ball head 12/14 ø 28 size l +3.5, lot 176812 (k112115): (b)(4) items manufactured and released on 29-mar-2018.Expiration date: 2023-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 3 similar reported event.Liner: mpact dm 01.26.2852mhc double mobility hc liner 28/dmf lot 168641 (k092265): (b)(4) items manufactured and released on 14-mar-2019.Expiration date: 2022-02-22.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 01.32.152mb double mobility acetabular shell ø52, lot 185435 (k143453): (b)(4) items manufactured and released on 07-dec-2018.Expiration date: 2023-11-26.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.
Event or Problem Description
About 3 months and a half after primary the surgeon revised the patient hip for an infection.The pathogen is unknown.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H 01.12.20SN CEMENTLESS, HA COATED STD STEM SIZE 0, 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: 8883102
• Report Number: 3005180920-2019-00681
• Device Sequence Number: 14043809
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• 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): 08/12/2019

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: 01.12.20SN
• Device Lot Number: 187005
• 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: 08/12/2019
• 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