MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø52 MULTI-HOLE; HIP ACETABULAR SHELL

Model Number	01.32.152MH
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6)2023: lot 2106973: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-11-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by meadacta medical affairs manager: revision 1 year after the primary tha surgery due to a loose cup.The patient came in reporting pain.The cause of the loosening is unknown.The radiographic images lead us to suspect that the medial acetabular border could have been violated during cup insertion, therefore limiting the possibility of the cup to achieve stable steointegration.The surgeon revised successfully the cup, head and liner.
Event or Problem Description
At about 1 year after the primary surgery, the patient came in reporting pain due to a loose cup and the cause is unknown.The surgeon revised successfully the cup, head and liner.

• Brand Name: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
• Common Device Name: HIP ACETABULAR 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: 16893410
• Report Number: 3005180920-2023-00344
• Device Sequence Number: 6162762
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 05/09/2023

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 Model Number: 01.32.152MH
• Device Catalogue Number: 01.32.152MH
• Device Lot Number: 2106973
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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 Sex: Unknown