MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 22X43; ACETABULAR BIPOLAR HEAD

Model Number	25060.2243
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-oct-2020: lot 120244: (b)(4) items manufactured and released on 12-apr-2012.Expiration date: 28-feb-2017.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Additional implant involved: ball heads: cocr 01.25.124 cocr ball head 12/14 ø 22 size s -2,5 (k080885) lot.120541.Batch review performed on 13-oct-2020: lot 120541: (b)(4) items manufactured and released on 06-sep-2012.Expiration date: 28-feb-2017.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.
Event or Problem Description
The patient came in reporting acetabular discomfort 6 years and 6 months after the primary.The cause of the discomfort is unknown.The surgeon revised the patient's bipolar head and the cocr primary head.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD 22X43
• Common Device Name: ACETABULAR BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10689619
• Report Number: 3005180920-2020-00707
• Device Sequence Number: 19808119
• Product Code: KWY
• UDI-Device Identifier: 07630030843358
• UDI-Public: 07630030843358
• 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: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

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: 02/28/2017
• Device Model Number: 25060.2243
• Device Catalogue Number: 25060.2243
• Device Lot Number: 120244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/16/2020
• 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