MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES

Catalog Number	01.32.154DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 november 2023: lot 1811190: (b)(4) items manufactured and released on 21-mar-2019.Expiration date: 2024-03-11.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.Additional items involved in the complaints, batch review performed on 20 november 2023: liner: mpact 01.32.3644hct flat pe hc liner ø36/e (k103721) lot.1903449 lot 1903449: (b)(4) items manufactured and released on 23-may-2019.Expiration date: 2024-05-08.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.Ball heads: cocr 01.25.031 cocr ball head 12/14 ø 36 size m 0 (k080885) lot.1902383 lot 1903234: (b)(4) items manufactured and released on 17-jul-2019.Expiration date: 2024-07-07.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Stem: amistem p 01.18.435 amistem-p collared std stem size 5 (k173794) lot.1903234 lot 1902383: (b)(4) items manufactured and released on 28-aug-2019.Expiration date: 2024-08-18.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
At about 4 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer for a 2-stage infection protocol.The surgery was completed successfully.
Event or Problem Description
At about 4 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer for a 2-stage infection protocol.The surgery was completed successfully.On (b)(6) 2024, permanent implants were placed (about 4 years and 2 months after the primary surgery).
Additional Manufacturer Narrative
Additional information reported in this follow up: - event description updated because we have been informed that permanent implants were placed on (b)(6) 2024.The new description is: at about 4 years from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted all implants and placed an antibiotic spacer for a 2-stage infection protocol.The surgery was completed successfully.On (b)(6) 2024, permanent implants were placed (about 4 years and 2 months after the primary surgery).

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• 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: 18281395
• Report Number: 3005180920-2023-00960
• Device Sequence Number: 20385140
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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: 03/11/2024
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 1811190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2019
• 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