MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L; HIP CERAMIC HEAD

Model Number	01.29.203
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 july 2021: lot 174694: (b)(4) items manufactured and released on 23-gen-2018.Expiration date: 2023-01-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved batch review performed on 08 july 2021: ball heads: bipolar head 25060.2846 bipolar head ¿28x46 (k091967) lot 1908064: (b)(4) items manufactured and released on 12-dec-2019.Expiration date: 2024-11-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the bipolar head.The surgery was completed successfully.

• Brand Name: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L
• Common Device Name: HIP CERAMIC HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12179429
• Report Number: 3005180920-2021-00606
• Device Sequence Number: 1493080
• Product Code: LZO
• UDI-Device Identifier: 07630030809149
• UDI-Public: 07630030809149
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 07/16/2021

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: 01/11/2023
• Device Model Number: 01.29.203
• Device Catalogue Number: 01.29.203
• Device Lot Number: 174694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/16/2021
• 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