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

Catalog Number	01.32.150DH
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9601763
• Report Number: 3005180920-2019-01148
• Device Sequence Number: 2040957
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 161850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 64