MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50; HIP BIPOLAR HEAD

Catalog Number	25060.2850
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 august 2019: lot 1900866: (b)(4) items manufactured and released on 27-may-2019.Expiration date: 2024-05-15.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been already sold without any other similar reported event.Additional implants involved in the event, batch review performed on 13 august 2019: ball heads: mectacer 01.29.201 biolox delta ceramic ball head 12/14 ø 28 size s -3.5 (k112115) lot.1811825.Lot 1811825: (b)(4) items manufactured and released on 02-apr-2019.Expiration date: 2024-03-24.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.Stem: amistem-p collared 01.18.435 amistem-p collared std stem size5 (k173794), lot.1902249.Lot 1902249: (b)(4) items manufactured and released on 29-may-2019.Expiration date: 2024-05-20.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and removed all implants and put in new hardware 3 weeks after primary.The surgery was completed successfully.

• Brand Name: BALL HEADS: BIPOLAR HEAD BIPOLAR HEAD Ø28X50
• Common Device Name: HIP BIPOLAR HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8953779
• Report Number: 3005180920-2019-00750
• Device Sequence Number: 11287479
• Product Code: KWY
• UDI-Device Identifier: 07630030843716
• UDI-Public: 07630030843716
• 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: 2019
• 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): 09/02/2019

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: 05/15/2024
• Device Catalogue Number: 25060.2850
• Device Lot Number: 1900866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 09/02/2019
• 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