MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X53

Catalog Number	25060.2853
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 march 2019: lot 145525: (b)(4) items manufactured and released on 29-oct-2014.Expiration date: 2019-09-30.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.Additional implant involved: ball heads: cocr 01.25.011 cocr ball head 12/14 ø 28 size s -3.5 (k072857), lot 166587: (b)(4) items manufactured and released on 08-mar-2017.Expiration date: 2022-02-22.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
A revision surgery (washout and change of bipolar head and femoral head) after over a month has been successfully performed for suspected infection (pathogen not yet confirmed).

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X53
• Common Device Name: BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8394721
• Report Number: 3005180920-2019-00122
• Device Sequence Number: 16551224
• Product Code: KWY
• UDI-Device Identifier: 07630030843778
• UDI-Public: 07630030843778
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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: 09/30/2019
• Device Catalogue Number: 25060.2853
• Device Lot Number: 145525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/06/2019
• 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
• Patient Age: 68 YR
• Patient Weight: 90