MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX OPTION Ø 32; HIP CERAMIC BALL HEAD

Model Number	01.29.231H
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 january 2020: lot 1905667: (b)(4) items manufactured and released on 25-sep-2019.Expiration date: 2024-09-16.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.Additional devices involved: batch review performed on 29 january 2020: liner: mpact 01.32.3239hct flat pe hc liner 32/c (k103721) lot 1900216: (b)(4) items manufactured and released on 04-apr-2019.Expiration date: 2024-03-19.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.Cup: mpact 01.32.148dh acetabular shell 48 two-holes (k132879) lot 1902267: (b)(4) items manufactured and released on 10-jul-2019.Expiration date: 2024-06-30.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: quadra-h 01.12.21sn cementless, ha coated std stem size 1, short neck (k082792) lot 188789: (b)(4) items manufactured and released on 21-jan-2019.Expiration date: 2024-01-09.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.Screws: mpact 01.32.6520 cancellous bone screw, flat head 6,5 l 20 (k103721) lot 1905812: (b)(4) items manufactured and released on 12-aug-2019.Expiration date: 2024-07-22.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.Screws: mpact 01.32.6525 cancellous bone screw, flat head 6,5 l 25 (k103721) lot 1905813: (b)(4) items manufactured and released on 12-aug-2019.Expiration date: 2024-07-21.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 had a primary hip surgery on (b)(6) 2019.On (b)(6) 2020, the patient came in for a post-op appointment.It was observed that the patient had superficial wound drainage.The surgeon performed an i&d and revised the head and liner.The surgery was completed successfully.On (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER BIOLOX OPTION Ø 32
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9738114
• Report Number: 3005180920-2020-00078
• Device Sequence Number: 16598093
• Product Code: LZO
• UDI-Device Identifier: 07630030809330
• UDI-Public: 07630030809330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 09/16/2024
• Device Model Number: 01.29.231H
• Device Catalogue Number: 01.29.231H
• Device Lot Number: 1905667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/21/2020
• 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