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

Catalog Number	01.12.23SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 years and 4 months after primary, the patient came in reporting pain due to a potted stem.The surgeon revised the stem, head and liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22-dec-2023.Lot 157625: (b)(4) items manufactured and released on 26-apr-2016.Expiration date: 2021-04-10.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of the review.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18484164
• Report Number: 3005180920-2023-01081
• Device Sequence Number: 9154096
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: 04/10/2026
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 157625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White