MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø22X41

Catalog Number	25060.2241
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018.Lot 112862: (b)(4).Expiration date: 2016-03-30.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.Cocr ball head 12/14 ø 22 size s -2,5 reference 01.25.124 (k080885).Lot 134979: (b)(4).Expiration date: 2018-10-31.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
We were informed on (b)(6) 2018 that the patient came in complaining of pain.The surgeon plans to revise the patient on (b)(6) 2018.More information to follow the case.Update received on 13 september 2018: revision not performed on (b)(6) date unknown.To date no additional information are available.

• Brand Name: BIPOLAR HEAD Ø22X41
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7876589
• Report Number: 3005180920-2018-00686
• Device Sequence Number: 186780
• Product Code: KWY
• UDI-Device Identifier: 07630030843310
• UDI-Public: 07630030843310
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 03/30/2016
• Device Catalogue Number: 25060.2241
• Device Lot Number: 112862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/14/2018
• 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
• Patient Age: 48 YR