MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.146MH ACETABULAR SHELL 46 MULTI-HOLE

Model Number	01.32.146MH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 august 2021: lot 1906192: (b)(4) items manufactured and released on 30-oct-2019.Expiration date: 2024-oct-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: one year after hybrid tha in a young dysplastic lady patient both stem and cup are mobilized.For the stem, the pre-revision xray shows discontinued cement mantle and rather poor bone quality, although there is no mention of an infection or osteomalacia in the report.In the dysplastic acetabulum, it seems that in spite of the multihole configuration and the use of screws, the shallow acetabulum did not allow good pressfit to be established, notwithstanding the acetabular roof reconstruction.The report also mentions that similar symptoms are being reported from the contralateral side, which is a rather significant aspect that may lead to think that a systemic disorder is in place.No final conclusion can be reached, but except the cement mantle on the femoral side we can see no anomalies in the implantation procedure, and also the cement mantle is hardly sufficient cause for an early loosening.
Event or Problem Description
The primary surgery performed on (b)(6) 2020.The patient came to the hospital (b)(6) 2021 and the surgeon noticed loosening of cup and stem.The revision surgery performed on (b)(6) 11 months after the primary surgery.The reason which occurred gap and/or loosening at acetabular side is not clear.

• Brand Name: CUP: MPACT 01.32.146MH ACETABULAR SHELL 46 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12475428
• Report Number: 3005180920-2021-00746
• Device Sequence Number: 19818245
• Product Code: LPH
• UDI-Device Identifier: 07630030810718
• UDI-Public: 07630030810718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 09/15/2021

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: 10/20/2024
• Device Model Number: 01.32.146MH
• Device Catalogue Number: 01.32.146MH
• Device Lot Number: 1906192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/15/2021
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 56