MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø22X43

Catalog Number	25060.2243
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8164764
• Report Number: 3005180920-2018-01005
• Device Sequence Number: 16661379
• Product Code: KWY
• UDI-Device Identifier: 07630030843358
• UDI-Public: 07630030843358
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 09/30/2019
• Device Catalogue Number: 25060.2243
• Device Lot Number: 145514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention