MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

Model Number	01.29.202
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 february 2022.Lot 2012905: (b)(4) items manufactured and released on 09-apr-2021.Expiration date: 2026-03-25.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.Other devices involved: batch review performed on 18 february 2022: liner: versafitcup dm 01.26.2852mhc double mobility hc liner ø 52/28 (k092265) lot 2103099: (b)(4) items manufactured and released on 30-apr-2021.Expiration date: 2026-04-18.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.Stem: quadra-h 01.12.033 cementless, ha coated lat stem # 3 (k082792) lot 182834: (b)(4) items manufactured and released on 19-sep-2018.Expiration date: 2023-09-05.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.Cup: versafitcup 01.26.52mb acetabular shell ø 52 (k083116) lot 188841: (b)(4) items manufactured and released on 15-feb-2019.Expiration date: 2024-02-06.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2019.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the head and liner.Presently, on (b)(6) 2022, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components, performed a washout, and reimplanted new components.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M
• Common Device Name: CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13826438
• Report Number: 3005180920-2022-00181
• Device Sequence Number: 1000021
• Product Code: LZO
• UDI-Device Identifier: 07630030809132
• UDI-Public: 07630030809132
• Combination Product (Y/N): N
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2022

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: 03/25/2026
• Device Model Number: 01.29.202
• Device Catalogue Number: 01.29.202
• Device Lot Number: 2012905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female