MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD 28X5

Model Number 25060.2851

Device Problem Degraded (1153)

Patient Problem Osteolysis (2377)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30 march 2021: lot 177753: (b)(4) items manufactured and released on 09-feb-2018.Expiration date: 2023-01-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in reporting pain.The surgeon discovered that the patient's acetabulum was worn out due to osteolysis.2 years and 3 months after primary the surgeon revised successfully the bipolar head and it's internal ceramic head.No signs of damage found on the bipolar head.

• Brand Name: BALL HEADS: BIPOLAR HEAD 28X5
• Type of Device: 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: 11705861
• MDR Text Key: 246688313
• Report Number: 3005180920-2021-00313
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843730
• UDI-Public: 07630030843730
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: 25060.2851
• Device Catalogue Number: 25060.2851
• Device Lot Number: 177753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention