MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BIPOLAR HEAD Ø28X44

Catalog Number	25060.2844
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2018; lot 171298: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-06-06 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.Cocr ball head 12/14 ø 28 size m 0 reference 01.25.012 (k072857); lot 174665:(b)(4) items manufactured and released on 18 october 2017.Expiration date: 2022-10-08 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
Patient had infection 3 weeks after primary: the surgeon believed that it was more of a superficial infection, but as a preventative he changed out the bipolar head and the femoral head.He also took samples and as the results came back (b)(6) for (b)(6) , on (b)(6) 2018 he performed another washout and removed the head lot 176024 and the bipolar head lot 171298.

• Brand Name: BIPOLAR HEAD Ø28X44
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7510727
• Report Number: 3005180920-2018-00325
• Device Sequence Number: 16450285
• Product Code: KWY
• UDI-Device Identifier: 07630030843594
• UDI-Public: 07630030843594
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 06/06/2022
• Device Catalogue Number: 25060.2844
• Device Lot Number: 171298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2018
• Initial Report FDA Received Date: 05/14/2018
• 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 Weight: 45