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

Catalog Number	01.32.150DH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 may 2018; lot 170134: (b)(4) items manufactured and released on 05 may 2017.Expiration date: 2022-04-23 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.Amistem h ha coated std stem size 1 reference 01.18.131 (k093944); lot 148430: (b)(4) items manufactured and released on 31 march 2015.Expiration date: 2020-02-29; 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.Cocr ball head 12/14 ø 32 size xxl +10.5 reference 01.25.025 (k072857); lot 162371: (b)(4) items manufactured and released on 05 july 2016.Expiration date: 2021-06-21; 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 mpact flat pe hc liner ø32/d reference 01.32.3241hct (k103721); lot 171736: (b)(4) items manufactured and released on 28 july 2017.Expiration date: 2022-07-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.
Event or Problem Description
The patient had a primary surgery on (b)(6) 2017.In (b)(6) 2017 came in due to signs of infection and the surgeon performed an i&d and swapped the head and liner.The pathogen is unknown.(b)(4).On (b)(6) 2018 the patient is being revised for infection [staphilococcus].The surgeon revised all components and implanted a spacer containing a medacta liner.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
• Common Device Name: ACETABULAR SHELL Ø50 TWO-HOLES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7540699
• Report Number: 3005180920-2018-00360
• Device Sequence Number: 13921197
• Product Code: LPH
• UDI-Device Identifier: 07630030810763
• UDI-Public: 07630030810763
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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: 04/23/2022
• Device Catalogue Number: 01.32.150DH
• Device Lot Number: 170134
• 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: 04/24/2018
• Initial Report FDA Received Date: 05/24/2018
• 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