MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 48 TWO-HOLES

Catalog Number	01.32.148DH
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regualtory affairs department on (b)(6) 2020: lot 1900178: 130 items manufactured and released on 10-may-2019.Expiration date: 2024-04-30.No anomalies found related to the problem.To date, 117 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: 9 months after cementless total hip arthroplasty in a (b)(6) year old woman, the position of the acetabular cup appears to be inadequate.This position may be due to a postoperative migration but this cannot be confirmed on the basis of the single pre-revision x-ray provided.Bone formation is visible on the explanted cup.The cause of this event cannot be determined.Preliminary investigation performed by r&d project manager: from the received photo it is not possible to determine any root cause related to the event, but it seems that the event was not caused by any implant defect.
Event or Problem Description
The surgeon revised the cup, ball head, and liner due to the mobilization which caused the malpositioning of the cup after 9 months from the primary surgery.During the primary surgery the cup was in the correct position.

• Brand Name: CUP: MPACT ACETABULAR SHELL 48 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10224640
• Report Number: 3005180920-2020-00382
• Device Sequence Number: 18966812
• Product Code: LPH
• UDI-Device Identifier: 07630040720250
• UDI-Public: 07630040720250
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 04/30/2024
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 1900178
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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: 59 YR
• Patient Weight: 113