MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK; HIP CEMENTLESS STEM

Model Number	01.12.33SN
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2021.Lot 141072c: (b)(4) item manufactured and released on 28-aug-2019.Expiration date: 2024-07-29.No anomalies found related to the problem.
Event or Problem Description
The patient came in for primary hip surgery on (b)(6) 2021.During post-op recovery, the surgeon reviewed post-op x-rays that indicated the patient had too much offset.The surgeon decided to revise the stem and head on the same day of primary surgery.The surgery was completed successfully.Quadra h sn standard has been implanted.
Additional Manufacturer Narrative
Batch review was corrected on 09-june-2021.Also device availability (section d9) has been corrected.Batch review performed on 09 june 2021.Lot 141072c: 1 item re-sterilized and released on 28-aug-2019.Expiration date: 2024-07-29.No anomalies found related to the problem.Note that lot 141072c is a re-sterilization of lot 141072.Lot 141072: 15 items manufactured and released on 10-apr-2014.Expiration date: 2025-07-20.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, 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: 11654727
• Report Number: 3005180920-2021-00287
• Device Sequence Number: 3606445
• Product Code: JDI
• UDI-Device Identifier: 07630030802737
• UDI-Public: 07630030802737
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 07/29/2024
• Device Model Number: 01.12.33SN
• Device Catalogue Number: 01.12.33SN
• Device Lot Number: 141072C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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
• Patient Age: 65 YR