MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø22X43

Catalog Number 25060.2243

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 november 2018.Lot 145514: (b)(4) items manufactured and released on 14 november 2014.Expiration date: 2019-09-30.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved cocr ball head 12/14 ø 22 size m 0 reference (b)(4).Lot 155860: (b)(4) items manufactured and released on 14 january 2016.Expiration date: 2020-12-16 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, 2 years and 4 months after primary surgery, due to a dislocation of the head from the acetabulum.The surgeon revised the femoral head and bipolar head and replaced them with a femoral head, cup and liner.The surgery was completed successfully.

• Brand Name: BIPOLAR HEAD Ø22X43
• Type of Device: 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: 8164764
• MDR Text Key: 130357740
• Report Number: 3005180920-2018-01005
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07630030843358
• UDI-Public: 07630030843358
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 25060.2243
• Device Lot Number: 145514
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2014
• 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