MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 52 NO-HOLE; ACETABULAR SHELL NO HOLE

Model Number	01.32.152SH
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 january 2021: lot 165749: (b)(4) items manufactured and released on 24-nov-2016.Expiration date: 2021-11-14.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 since 2017.
Event or Problem Description
The patient came in reporting pain due to cup impingement.The surgeon revised the cup and liner to a competitor cup and liner 4 months after the primary surgery, the surgery was completed successfully.The reason the patient had a cup impingement is because during the primary surgery, the cup was misplaced and undersized/over-reamed in combination with the patient having a spinal issue that makes the rom challenging to access under anesthesia.

• Brand Name: CUP: MPACT ACETABULAR SHELL 52 NO-HOLE
• Common Device Name: ACETABULAR SHELL NO HOLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11321462
• Report Number: 3005180920-2021-00106
• Device Sequence Number: 4140143
• Product Code: LPH
• UDI-Device Identifier: 07630030810817
• UDI-Public: 07630030810817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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: 11/14/2021
• Device Model Number: 01.32.152SH
• Device Catalogue Number: 01.32.152SH
• Device Lot Number: 165749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/12/2021
• 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