MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3DMETAL ACETABULAR SHELL 48 TWO-HOLE

Catalog Number 01.38.048DH

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1810873: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2024-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Other device involved in the event: ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 lot.1811283 (k072857).Batch review performed by medacta regulatory affairs department on 10 july 2020: lot 1811283: (b)(4) items manufactured and released on 08-may-2019.Expiration date: 2024-04-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in 9months after the primary surgery reporting instability and the cause of the instability is unknown.The surgeon revised the cup and head and the surgery was completed successfully.There is no information about any implant mobilization.

• Brand Name: CUP: MPACT 3DMETAL ACETABULAR SHELL 48 TWO-HOLE
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10331239
• MDR Text Key: 200590787
• Report Number: 3005180920-2020-00456
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812576
• UDI-Public: 07630030812576
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: 01.38.048DH
• Device Lot Number: 1810873
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2019
• 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: 66 YR