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

Model Number 01.32.152MH

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/14/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 314800584
• Report Number: 3005180920-2023-00344
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030810800
• UDI-Public: 07630030810800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 01.32.152MH
• Device Catalogue Number: 01.32.152MH
• Device Lot Number: 2106973
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2021
• 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