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

Catalog Number	01.29.215
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At about 1 year from the primary the surgeon performed a washout, removed all implants, and implanted new implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01 september 2023: lot 2203067: (b)(4) items manufactured and released on 25-may-2022.Expiration date: 2027-05-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Additional involved implants batch review performed on 01 september 2023 on cup: mpact 01.32.164dh acetabular shell ø64 two-holes (k132879) lot.2000236.Lot 2000236: (b)(4) items manufactured and released on 06-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 without any similar reported event in the period of review.Batch review performed on 01 september 2023 on liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot.2111817.Lot 2111817: (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 2026-09-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Batch review performed on 01 september 2023 on stem: sms solid 01.36.053 sms solid stem std size 13 (k181693) lot.2100581.Lot 2100581: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
On 29 november 2023 after additional checks with the branch we found that the patient was already involved in other surgeries reported in other complaint.Same patient of mdr 2022-00637, 2022-00696, 2023-00238.We modified the patient gender (male), the date of the surgery ((b)(6) 2023) and the event description.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At about 5 months after a precedent surgery for infection the surgeon performed a washout, removed all implants, and implanted new implants.The surgery was completed successfully.

• Brand Name: BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL
• 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: 17773625
• Report Number: 3005180920-2023-00737
• Device Sequence Number: 6455061
• Product Code: LZO
• UDI-Device Identifier: 07630030809262
• UDI-Public: 07630030809262
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Catalogue Number: 01.29.215
• Device Lot Number: 2203067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2022
• 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 Age: 61 YR
• Patient Sex: Male