MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 MULTI-HOLE THIN; HIP CUP

Model Number	01.38.348MH
Medical Device Problem Codes	Osseointegration Problem (3003); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 january 2023: lot 2005568: 96 items manufactured and released on 03-aug-2020.Expiration date: 2025-07-23.No anomalies found related to the problem.To date, 21 items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
At 5 months after primary the surgeon revised the patient hip for mpact mh 3d metal mobilization.Competitor plates and apricot used to complete the surgery.Surgeon comment: although it was not clear from the ct, the mri showed that the bones had fractured at the base of the acetabulum, which may have caused the cup to move without bone adhesion.
Event or Problem Description
Corrected description: at 5 months after primary, the surgeon revised the patient's hip due to mobilization of the impact mh 3d metal cup following a fracture of the acetabulum.Competitor plates and apricot used to complete the surgery.Surgeon commented: although it was not clear from the ct, the mri showed that the bones had fractured at the base of the acetabulum, which may have caused the cup to move without bone adhesion.
Additional Manufacturer Narrative
Additional information: device returned data: 02/15/2023.Visual inspection performed by r&d project manager: the cup did not shw any particular sign or damage; fibrotic tissue was present on its surface, indicating an initial proper fixation with the bone, while the internal surface showed some signs most probably related to the removal of the shell and liner.The liner appeared damaged for the use of screws during the removal.In addition, some scratches were evident on the inner surface and some signs of small black scratches were also present on the surface of the ceramic ball head.The reason of these signs is probably related to a third-body-wear, occurred during a probable contact between stem neck and shell rim after the verticalization of the shell.The root cause of the event is unknown but, according to the thought of the surgeon, the bone fracture seems to be the most accredited cause.Clinical evaluation performed by medical affairs department: revision of the cup 5 months after total hip arthroplasty due to cup loosening.According to report, the patient had pain and the surgeon found through mri images a fracture of the acetabulum.Due to low quality of the radiographic images, no information can be found apart from a malpositioning of the cup pre-revision.While from the mri images, the cup again seems suboptimal and the lamina quadrilatera appears thin: maybe it could not withstand the reaming and surgical preparation and therefore the acetabular cup could not reach sufficient stability.Competitor plates and apricot were used to complete the revision surgery.The surgeon thinks that the fracture is the cause of cup mobilization.There is no reason to suspect a faulty device.

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø48 MULTI-HOLE THIN
• Common Device Name: HIP CUP
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16334678
• Report Number: 3005180920-2023-00017
• Device Sequence Number: 17851336
• Product Code: LPH
• UDI-Device Identifier: 07630971212565
• UDI-Public: 07630971212565
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 07/23/2025
• Device Model Number: 01.38.348MH
• Device Catalogue Number: 01.38.348MH
• Device Lot Number: 2005568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian