MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X46

Catalog Number	25060.2846
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 july 2018.Lot 175687: (b)(4) items manufactured and released on 12 december 2017.Expiration date: 2022-11-26.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.Reference 01.25.013 (k072857) cocr ball head 12/14 ø 28 size l +3.5.Lot 174668: (b)(4) items manufactured and released on 15 november 2017.Expiration date: 2022-10-26.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 signs of infection 1 month after primary.The pathogen confirmed as enterococcus faecalis.The surgeon washed out the hip and revised the bipolar head and cocr head.The surgery was completed successfully.

• Brand Name: BIPOLAR HEAD Ø28X46
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7706393
• Report Number: 3005180920-2018-00523
• Device Sequence Number: 16326786
• Product Code: KWY
• UDI-Device Identifier: 07630030843631
• UDI-Public: 07630030843631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 11/26/2022
• Device Catalogue Number: 25060.2846
• Device Lot Number: 175687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/20/2018
• 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: 53 YR