MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD 25060.2855 BIPOLAR HEAD Ø28X55; FEMORAL BIPOLAR HEAD

Catalog Number	25060.2855
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 1 february 2019: lot 165878: (b)(4) items manufactured and released on 13-dec-2016.Expiration date: 2021-11-23.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.Additional implant revised:ball heads: cocr 01.25.012 cocr ball head 12/14 ø 28 size m 0 (k072857), lot 179173: (b)(4) items manufactured and released on 26-mar-2018.Expiration date: 2023-03-14.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 due to a recurring dislocation after 2 months from the primary surgery (bi-polar component dislocated from the acetabulum).The surgeon determined that a revision is required and removed the bi-polar head as well as the inner 28mm diameter head and converting it to a total hip using zimmer-biomet constrained liner.He preserved the stem.

• Brand Name: BIPOLAR HEAD 25060.2855 BIPOLAR HEAD Ø28X55
• Common Device Name: FEMORAL BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8296125
• Report Number: 3005180920-2019-00014
• Device Sequence Number: 16632546
• Product Code: KWY
• UDI-Device Identifier: 07630030843815
• UDI-Public: 07630030843815
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: 11/23/2021
• Device Catalogue Number: 25060.2855
• Device Lot Number: 165878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 02/01/2019
• 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