MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø54

Catalog Number	01.32.154MB
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 14 may 2019: lot 188881: (b)(4) items manufactured and released on 13-mar-2019.Expiration date: 2024-02-27.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 or Problem Description
During the primary hip surgery and after implanting the 54mm mpact dm cup, the cup disengaged and spun out while the hip was taken through range of motion.The surgeon re-implanted the cup and it disengaged and spun out again.The surgeon chose to implant a 54mm mpact two hole cup and 2 mpact dome screws for better fixation and the cup was stable through range of motion.Trials were inserted and the hip was taken through range of motion.The trials were removed and permanent implants were implanted.The surgeon was unable to reduce the hip after multiple attempts and decided to remove the 36mm biolox delta head l.A 36mm biolox delta head m was implanted and the surgeon was able to reduce the hip.The surgery was completed successfully removing all components except for the stem.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø54
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8615718
• Report Number: 3005180920-2019-00394
• Device Sequence Number: 19365448
• Product Code: LPH
• UDI-Device Identifier: 07630030860980
• UDI-Public: 07630030860980
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2024
• Device Catalogue Number: 01.32.154MB
• Device Lot Number: 188881
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 05/16/2019
• 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: Other