MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL 52 TWO-HOLES; HIP ACETABULAR SHELL

Model Number	01.32.152DH
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 november 2020: lot 181633: (b)(4) items manufactured and released on 27-jun-2018.Expiration date: 202-06-19.No anomalies found related to the problem.To date, 147 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain an instability 2 years and 2 months after the primary surgery.The post-op x-rays showed that the cup was anteverted.The cause of the anteverted cup is unknown.The surgeon revised the cup and liner with competitor products and revised the 36mm biolox delta head m with a 36mm biolox option head.The surgeon also added a biolox option sleeve l.The surgery was completed successfully.It is unknown if any traumatic event influenced on the prosthesis.

• Brand Name: MPACT ACETABULAR SHELL 52 TWO-HOLES
• Common Device Name: HIP ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10926502
• Report Number: 3005180920-2020-00865
• Device Sequence Number: 16322640
• Product Code: LPH
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• 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): 12/01/2020

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: 06/19/2023
• Device Model Number: 01.32.152DH
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 181633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 12/01/2020
• 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