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

Model Number	01.12.31SN
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	08/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08-aug-2022: lot 182707: 38 items manufactured and released on 20-jul-2018.Expiration date: 2023-07-11.No anomalies found related to the problem.To date, 29 items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
At about 2 months after the primary surgery, revision was performed due to implant loosening probably caused by a suspected fracture in the femur bone.Any fracture was noticed during the primary surgery.During the revision surgery a fracture was noticed but the reason is unknown.The surgeon revised successfully the head with a ceramic head and stem with a quadra-c stem and implanted a competitor plate.
Additional Manufacturer Narrative
Corrected data d4: the correct device reference is (b)(6).G3: date received by manufacturer is 08-05-2022., h6: medical device proble code is 3003.Additional info d4: the device expires on 07-11-2023.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT 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
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15319223
• Report Number: 3005180920-2022-00668
• Device Sequence Number: 5203708
• Product Code: JDI
• UDI-Device Identifier: 07630030802713
• UDI-Public: 07630030802713
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/30/2022

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 Model Number: 01.12.31SN
• Device Catalogue Number: 01.12.31SN
• Device Lot Number: 182707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2018
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White