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); No Code Available (3191)
Date of Event	10/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28 august 2018; lot 155986: (b)(4) items manufactured and released on 03 march 2016 expiration date: 2021-02-21.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.
Event or Problem Description
The patient came in complaining of pain 1 year and 9 months after primary surgery.The surgeon determined that the cup had migrated over time.The cause of the migration is unknown.The surgeon revised the cup, liner and head.The surgeon revised the cup and liner with another company's product.The surgeon revised the head with another medacta head.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: 7832924
• Report Number: 3005180920-2018-00647
• Device Sequence Number: 19223895
• Product Code: LPH
• UDI-Device Identifier: 07630030810701
• UDI-Public: 07630030810701
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: 02/21/2021
• Device Catalogue Number: 01.32.146DH
• Device Lot Number: 155986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• 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
• Patient Age: 77 YR