MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP CEMENTLESS SHELL

Catalog Number 01.32.154DH

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13-dec-2023: lot 2105762: (b)(4) items manufactured and released on 25-aug-2021.Expiration date: 2026-07-27.No anomalies found related to the problem.To date, 143 items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved.Batch review performed on 13-dec-2023: liner: mpact 01.32.3644hct flat pe hc liner 36/e (k103721) lot 2107100: (b)(4) items manufactured and released on 18-jun-2021.Expiration date: 2026-06-08.No anomalies found related to the problem.To date, 151 items of the same lot have been sold with another similar reported case during the period of review.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 36 size m 0 (k112115) lot 2111077: (b)(4) items manufactured and released on 14-dec-2021.Expiration date: 2026-11-29.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported case during the period of review stem: m-vizion 01.22.001 proximal body ø20mm l 40mm std (k170690) lot 155506a: (b)(4) items manufactured and released on 14-sep-2021.Expiration date: 2026-08-29.No anomalies found related to the problem.

Event Description

The patient had a primary hip surgery on (b)(6) 2021.Subsequently, the patient came in reporting pain due to a loose stem.On (b)(6) 2022, the surgeon revised the stem and head successfully.Presently, the patient came in sue to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the cup, liner, head and proximal body and the surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Type of Device: HIP CEMENTLESS 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: 18364400
• MDR Text Key: 330995957
• Report Number: 3005180920-2023-01047
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• 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
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 2105762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2021
• 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 Age: 57 YR
• Patient Sex: Male