MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 2; HIP UNCEMENTED STEM

Model Number	01.12.022
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 16 june 2020: lot 090854: (b)(4) items manufactured and released on 25-may-2009.Expiration date: 2014-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with no other similar reported event since 2016.Preliminary investigation performed by medacta r&d hip project manager: explant covered in biological fluids with signs of extraction on the taper.Clinical evaluation performed by medacta medical affairs director: hip revision surgery performed more than 12 years after cementless total hip arthroplasty in a (b)(6) year old man.Radiographic image provided shows the radiological stem loosening.According to the report, the stem subsided in the femur but this cannot be confirmed on the basis of the single partial image provided.The reason for this event cannot be determined.
Event or Problem Description
Revision surgery performed 12 years and 5 months after the primary surgery due to pain caused by stem mobilization (scintigraphy showed also radiolucency).In the end of (b)(6), the stem goes down and the pain is unbearable for the patient.The surgeon revised the stem (amistem c) and ball head (ceramic 32 l) and implanted mectaplug size 1.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 2
• Common Device Name: HIP UNCEMENTED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10229107
• Report Number: 3005180920-2020-00377
• Device Sequence Number: 573294
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2020

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: 04/30/2014
• Device Model Number: 01.12.022
• Device Catalogue Number: 01.12.022
• Device Lot Number: 090854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 07/03/2020
• 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: 78 YR
• Patient Weight: 69