MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58; HIP DOUBLE MOBILITY SHELL

Catalog Number	01.32.158MB
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 march 2024: lot 1905349: (b)(4) items manufactured and released on 11-nov-2019.Expiration date: 2024-nov-02.No anomalies found related to the problem.To date, 28 items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed on 04 april 2024 by medacta hip r&d project manager: from the received pieces, no particular evident signs of defects were noticed.Some bone tissue was still present on the coating surface and some small signs were present on the rim, probably occurred during the contact with the bone.From the received information it was not possible to determine with certainty the root cause of the event, but a probable cause can be related to the contact between the rim of the impaction plate with the acetabular bone rim, that could have caused a lever effect that disengaged the shell from the acetabular seat.
Event or Problem Description
Mpact dm cup dislocated from the acetabular wall when the surgeon tried to disengage the cup impactor.The surgeon thinks that the dislocation is related to the cup impactor because the plate interfered with the acetabular bone so the unscrewing was difficult.The osteophytes were carefully removed during acetabular preparation.The surgeon dropped double mobility because of the risk of dislocation and implanted an mpact cup 2-holes with 2 screws.The dislocation and the need to ream the acetabulum again caused 2.5 hours of delay.

• Brand Name: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58
• Common Device Name: HIP DOUBLE MOBILITY SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19039946
• Report Number: 3005180920-2024-00173
• Device Sequence Number: 20969546
• Product Code: LPH
• UDI-Device Identifier: 07630030861000
• UDI-Public: 07630030861000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: 11/02/2024
• Device Catalogue Number: 01.32.158MB
• Device Lot Number: 1905349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian