MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES

Model Number 01.32.156DH

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/28/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 january 2022.Lot 2100137: (b)(4) items manufactured and released on 26-march-2021.Expiration date: 2026-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

At 1 month and a half after the primary, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup, liner, and head.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 31 january 2022.Lot 2100137: (b)(4) items manufactured and released on 26-march-2021.Expiration date: 2026-03-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

At 1 month and a half after the primary, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup, liner, and head.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13584649
• MDR Text Key: 286045539
• Report Number: 3005180920-2022-00140
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2022

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 Model Number: 01.32.156DH
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 2100137
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2021
• 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 Sex: Male