MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44; HIP BIPOLAR HEAD

Model Number 25060.2844

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Implant Pain (4561)

Event Date 01/19/2023

Event Type  Injury  

Event Description

The patient came in reporting pain due to a dislocation of the bipolar shell from the acetabulum.The cause of the dislocation is unknown.At about 2 months from the primary the surgeon revised the patient from a hemi to a total hip.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 20 january 2023: lot 1901960: (b)(4) items manufactured and released on 22-july-2019.Expiration date: 2024-07-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44
• Type of Device: HIP BIPOLAR HEAD
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16385149
• MDR Text Key: 309645385
• Report Number: 3005180920-2023-00049
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843594
• UDI-Public: 07630030843594
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2023

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
• Device Operator: Health Professional
• Device Model Number: 25060.2844
• Device Catalogue Number: 25060.2844
• Device Lot Number: 1901960
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2019
• 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
• Patient Sex: Female