MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 58 MULTI-HOLE

Model Number	01.32.158MH
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 april 2021.Lot 1811208: (b)(4) items manufactured and released on 17-apr-2019.Expiration date: 2024-04-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Revision surgery performed following cup loosening after about 2 years from the primary surgery.Primary performed in 2019, exact date unknown.
Additional Manufacturer Narrative
On (b)(6) we were informed about the primary surgery date.The event description has been updated.
Event or Problem Description
Revision surgery performed following cup loosening 1 year and 4 months after primary.

• Brand Name: CUP: MPACT ACETABULAR SHELL 58 MULTI-HOLE
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11743642
• Report Number: 3005180920-2021-00336
• Device Sequence Number: 19861799
• Product Code: LPH
• UDI-Device Identifier: 07630030810909
• UDI-Public: 07630030810909
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 04/03/2024
• Device Model Number: 01.32.158MH
• Device Catalogue Number: 01.32.158MH
• Device Lot Number: 1811208
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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: 70 YR