MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES

Catalog Number 01.32.158DH

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 11/17/2023

Event Type  Injury  

Event Description

The patient came in due to signs of infection and the pathogen is unknown.About 5 years and 4 months after the primary surgery, the surgeon removed all implants and placed an antibiotic spacer per the 2-stage infection protocol.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 24 november 2023.Lot 166611: (b)(4) items manufactured and released on 01-feb-2017.Expiration date: 2022-jan-22.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 24 november 2023: liner: mpact 01.32.3648hct flat pe hc liner ø36/f (k103721) lot.171741.Lot 171741: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 2022-sep-03.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.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot.172272.Lot 172272: (b)(4) items manufactured and released on 31-jul-2017.Expiration date: 2022-sep-03.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: masterloc 01.39.208 cementless ti coated lat stem size 8 (k151531) lot.171332.Lot 171332: (b)(4) items manufactured and released on 04-oct-2017.Expiration date: 2022-sep-24.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.

Manufacturer Narrative

On (b)(6) 2024, permanent implants have been placed.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLES
• Type of Device: 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: 18299556
• MDR Text Key: 330111666
• Report Number: 3005180920-2023-01034
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: 01.32.158DH
• Device Lot Number: 166611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male