MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M; HIP CERAMIC BALL HEAD

Catalog Number	01.29.213
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 november 2023 lot 2107507: (b)(4) items manufactured and released on 21-sep-2021.Expiration date: 2026-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review clinical evaluation performed by medical affairs department late infection in cemented tha,1 year and 5 months after previous revision.This is the third revision due to infection.From the radiographic image it is visible the subpoptimal position of the stem which it may be due to the loosening of the stem.According to report, the loosening happened due to the infection.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Additional involved implants batch review performed on 10 november 2023 on mectaplug 01.33.101 mectaplug pe size 1 lot.2115071 lot 2115071: (b)(4) items manufactured and released on 22-dec-2021.Expiration date: 2026-12-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.This product is not marketed in us.Batch review performed on 10 november 2023 on screws: mpact 01.32.6535 cancellous bone screw, flat head ø 6,5 l 35 (k103721) lot.2101235 lot 2101235: (b)(4) items manufactured and released on 26-mar-2021.Expiration date: 2026-03-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review batch review performed on 10 november 2023 on screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.2109249 lot 2109249: (b)(4) items manufactured and released on 29-sep-2021.Expiration date: 2026-09-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review batch review performed on 10 november 2023 on liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot.2001310 lot 2001310: (b)(4) items manufactured and released on 12-may-2020.Expiration date: 2025-04-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 10 november 2023 on cup: mpact 01.32.162dh acetabular shell ø62 two-holes (k132879) lot.179346 lot 179346: (b)(4) items manufactured and released on 15-may-2018.Expiration date: 2023-05-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review batch review performed on 10 november 2023 on shell screw plug: mpact 01.31.55tp shell screw plug (k103721) lot.2203098 lot 2203098: (b)(4) items manufactured and released on 11-apr-2022.Expiration date: 2027-03-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review batch review performed on 10 november 2023 on stem: quadra-c 01.12.044 cemented, mirror polishing std stem size 4 12/14 (k083558) lot.2000273 lot 2000273: (b)(4) items manufactured and released on 19-may-2020.Expiration date: 20256-05-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient underwent revision surgery due to infection on (b)(6) 2021, the patient underwent revision surgery due to infection that caused loosening of the implants.The surgeon explanted all insitu implants and will replace them with cemented implants once the infection clears up.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE M
• Common Device Name: HIP CERAMIC BALL HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18272889
• Report Number: 3005180920-2023-00935
• Device Sequence Number: 3954466
• Product Code: LZO
• UDI-Device Identifier: 07630030809248
• UDI-Public: 07630030809248
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 12/06/2023

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: 09/07/2026
• Device Catalogue Number: 01.29.213
• Device Lot Number: 2107507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2021
• 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: Male