MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK; HIP STEM CEMENTLESS

Model Number	01.12.34SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for stem loosening at about 6 years and 11 months post primary.Stem, head and liner revised successfully.
Additional Manufacturer Narrative
Batch review performed on 29 march 2023: lot 153559: 14 items manufactured and released on 24-aug-2015.Expiration date: 2020-07-26.No anomalies found related to the problem.To date, 11 items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK
• Common Device Name: HIP STEM CEMENTLESS
• 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: 16785172
• Report Number: 3005180920-2023-00276
• Device Sequence Number: 12143079
• Product Code: LZO
• UDI-Device Identifier: 07630030802744
• UDI-Public: 07630030802744
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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: 07/26/2020
• Device Model Number: 01.12.34SN
• Device Catalogue Number: 01.12.34SN
• Device Lot Number: 153559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2015
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 127 KG