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

Catalog Number	01.32.154DH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 november 2019.Lot 182590: 144 items manufactured and released on 24-jul-18.Expiration date: 2023-07-10.No anomalies found related to the problem.To date, 133 items of the same lot have been already sold with another similar reported event.Additional implant involved: stem: minimax 01.13.102r cementless anatomical stem right size 2 (k170845) lot.181827.Batch review performed on 22 november 2019.Lot 181827: 15 items manufactured and released on 11-jul-18.Expiration date: 2023-07-03.No anomalies found related to the problem.To date, 11 items of the same lot have been already sold with another similar reported event (event registered on the same lot is caused by trauma).Clinical evaluation performed by medical affairs manager.Hip revision surgery performed 8 months after cementless total hip arthroplasty in a 70 year old woman.Radiographic images provided show stem tilting from the initial position probably due to under sizing.The reason of this stem size choice is unknown: patient anatomy and bone morphology may have contributed but this cannot be confirmed on the basis of postoperative anteroposterior images.We cannot determine the causes of this event, but we see no reason to think that the prosthetic implants were defective.
Event or Problem Description
Revision surgery performed 9 months after the primary due to loose and tilted femoral stem and malpositioned cup.The cup and the stem were revised.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9409888
• Report Number: 3005180920-2019-01030
• Device Sequence Number: 17140556
• Product Code: LPH
• UDI-Device Identifier: 07630030810824
• UDI-Public: 07630030810824
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 07/10/2023
• Device Catalogue Number: 01.32.154DH
• Device Lot Number: 182590
• 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: 12/04/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 90