MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 48 TWO-HOLES; ACETABULAR CUP

Model Number	01.32.148DH
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-aug-2020: lot 182986: (b)(4) items manufactured and released on 04-sep-2018.Expiration date: 23-aug-2023.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.Additional mplant involved: liner: mpact 01.32.3239hct flat pe hc liner ø32/c (k103721) lot.185981.Batch review performed on 24-aug-2020: lot 185981: (b)(4) items manufactured and released on 25-sep-2018.Expiration date: 04-sep-2023.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
The patient came in reporting instability 1 year and 8 months after the primary surgery.The cause of the instability is unknown.The surgeon revised the cup and the liner.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL 48 TWO-HOLES
• Common Device Name: ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10507113
• Report Number: 3005180920-2020-00596
• Device Sequence Number: 3507603
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• 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): 09/09/2020

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: 08/23/2023
• Device Model Number: 01.32.148DH
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 182986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• 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