MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD Ø28X50; HIP BIPOLAR HEAD

Model Number	25060.2850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022 lot 2108688: 103 items manufactured and released on 31-aug-2021.Expiration date: 2026-08-16.No anomalies found related to the problem.To date, 84 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
At 23 days after the primary, the patient came in reporting pain due to a dislocation of the bipolar cup and femoral head from the acetabulum.The surgeon revised the bipolar cup and femoral head.The surgery was completed successfully.
Event or Problem Description
At 23 days after the primary, the patient came in reporting pain due to a dislocation of the bipolar cup and femoral head from the acetabulum that was caused from falling.The surgeon revised the bipolar cup and femoral head.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD Ø28X50
• Common Device Name: HIP 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: 15300397
• Report Number: 3005180920-2022-00646
• Device Sequence Number: 7307742
• Product Code: KWY
• UDI-Device Identifier: 07630030843716
• UDI-Public: 07630030843716
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2022

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 Model Number: 25060.2850
• Device Catalogue Number: 25060.2850
• Device Lot Number: 2108688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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