MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø50 TWO-HOLES

Catalog Number	01.32.150DH
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 may 2018.Lot 168438: (b)(4) items manufactured and released on 21 april 2017 expiration date: 2022-04-05 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.Other device involved: mpact flat pe hc liner ø32/d reference 01.32.3241hct (k103721).Lot 170976: (b)(4) items manufactured and released on 21 june 2017.Expiration date: 2022-06-07 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.Mectacer biolox delta ceramic ball head 12/14 ø 32 size m 0 reference 01.29.205 (k112115).Lot 171407: (b)(4) items manufactured and released on 08 june 2017.Expiration date: 2022-05-28 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.Clinical evaluation performed by medical affairs manager on 17 may 2018.Partial hip revision surgery occurred 6 months after primary cementless total hip arthroplasty.Patient was complaining about pain and the surgeon decided to revise cup, head and liner.The reason of pain cannot be determined on the basis of the radiographic image and information received.
Event or Problem Description
The patient came in complaining of groin pain 6 months after the primary.The cause of pain is unknown.The surgeon revised the cup, liner and head.The surgeon used another company's cup and liner with a medacta head.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø50 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: 7522297
• Report Number: 3005180920-2018-00337
• Device Sequence Number: 1176302
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 04/05/2022
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 168438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• 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