MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø46 TWO-HOLES

Catalog Number	01.32.146DH
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 july 2018; lot 178413: (b)(4) items manufactured and released on 30 march 2018.Expiration date: 11.03.2023 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional information received on 06 july 2018; based on the finding intra operative the cup was solid and correctly position.We had to up one size on the stem and on the femoral head we used an xl.
Event or Problem Description
We were informed on 08 june 2018 that before primary surgery the hip was found dislocated: the surgeon was able to put the hip in place in pre-op with little effort.Then, during the primary surgery, an mpact 2 hole shell was used, but no screws were used since the doctor determined it felt solid.The next day the patient continued with pain: the shell was found misplaced.On (b)(6) 2018 we were informed that the surgeon revised the cup, head, liner and stem.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø46 TWO-HOLES
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7666247
• Report Number: 3005180920-2018-00487
• Device Sequence Number: 13713171
• Product Code: LPH
• UDI-Device Identifier: 07630030810701
• UDI-Public: 07630030810701
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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: 03/11/2023
• Device Catalogue Number: 01.32.146DH
• Device Lot Number: 178413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/06/2018
• 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