MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES LOT. 161850

Catalog Number 01.32.150DH

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20 december 2019.Lot 161850: (b)(4) items manufactured and released on 13-sep-2016.Expiration date: 2021-08-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Preliminary investigation performed by r&d project manager from preliminary visual investigation it is not possible to determine an implant's related failure root cause.Clinical evaluation: revision surgery performed 3 years after cementless total hip arthroplasty in a (b)(6) man.Radiographic image provided shows a mobilized cup.Initial shell position cannot be determined as no immediate postoperative image is available.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.

Event Description

Acetabular cup loosening unknown cause, due to mobilization there was an impingement cup- stem.Cup, head and liner were revised almost 3 years and 3 weeks after primary.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES LOT. 161850
• 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: 9601763
• MDR Text Key: 176608453
• Report Number: 3005180920-2019-01148
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/17/2020

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 Expiration Date: 08/30/2021
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 161850
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2016
• 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: 71 YR
• Patient Weight: 64