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

Model Number	25060.2844
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2023-00049
• Device Sequence Number: 12046732
• Product Code: KWY
• UDI-Device Identifier: 07630030843594
• UDI-Public: 07630030843594
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2024
• Device Model Number: 25060.2844
• Device Catalogue Number: 25060.2844
• Device Lot Number: 1901960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2019
• 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 Sex: Female