MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X47 HIP ACETABULAR BIPOLAR HEAD

Model Number 25060.2847

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs department intraprosthetic dislocation 1 month after the partial hip prosthesis surgery in a 85 year old patient. Dislocation of the head from the bipolar cup is normally prevented by the retention mechanism. Technical analysis of the implant might reveal if a defect was present in said mechanism; to date we have no evidence of such situation. Conditions that may cause intra prosthetic dislocation in a well functioning bipolar cup are difficult to reproduce. With information at hand we are unable to draw any definitive conclusion. Batch review performed on (b)(6) 2022: lot 2103619: 12 items manufactured and released on (b)(6) 2021. Expiration date: (b)(6) 2026. No anomalies found related to the problem. To date, 4 items of the same lot have been sold without any similar reported event. Other device involved: ball heads: cocr 01. 25. 013 cocr ball head 12/14 ø 28 size l +3. 5, (k072857), lot. 2107132: 100 items manufactured and released on (b)(6) 2021. Expiration date: (b)(6) 2026. No anomalies found related to the problem. To date, 25 items of the same lot have been sold without any similar reported event.

Event Description

Luxation of the bipolar head from the metallic head (intra-prosthetic dislocation). The surgeon revised all components.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X47
• Type of Device: HIP ACETABULAR BIPOLAR HEAD
• 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: 14157400
• MDR Text Key: 289605019
• Report Number: 3005180920-2022-00272
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K091967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 25060.2847
• Device Catalogue Number: 25060.2847
• Device Lot Number: 2103619
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/20/2022 Patient Sequence Number: 1