MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø46 TWO-HOLES

Catalog Number	01.32.146DH
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2019.Lot 163227: 28 items manufactured and released on 25-jul-2016.Expiration date: 2021-07-12.No anomalies found related to the problem.To date, 19 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager: hip revision surgery performed 2,5 years after cementless total hip arthroplasty due to pain.On the basis of explant picture, the cup was well integrated: bone formation is visible on the surface.The origin of pain may be a suboptimal cup position that probably caused impingement with soft tissues.There is no reason to suspect a faulty device.Preliminary investigation performed by r&d project manager: the image shows the cup just explanted from the patient.It is covered by blood, and it is possible to note that the coating part is partially detached from the shell, probably due to an high fixation with the bone.As indicated by the surgeon, the cup was perfectly integrated, and it is not possible to determine the root cause of the event.
Event or Problem Description
The impact cup was removed because of the patient-reported pain 2.5 years after primary surgery.During the revision surgery, it was confirmed that the cup was perfectly integrated, and the infection samples were negative.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø46 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9443412
• Report Number: 3005180920-2019-01033
• Device Sequence Number: 11315207
• Product Code: LPH
• UDI-Device Identifier: 07630030810701
• UDI-Public: 07630030810701
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/10/2019

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: 07/12/2021
• Device Catalogue Number: 01.32.146DH
• Device Lot Number: 163227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/10/2019
• 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