MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

Catalog Number	01.26.45.1150
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 april 2018: versafitcup cc trio reference 01.26.45.1150 (k122911) acetabular shell cc trio no-hole ø 50 l.(b)(4).Reference 01.26.3244hct (k103352) flat pe hc liner ø 32 / e.(b)(4).Amistem h reference 01.18.130(k093944) ha coated std stem size 0.(b)(4).Ceramic ball head (not marketed in us): no anomaly found on the document review.Clinical evaluation performed by medical affairs director on 20 april 2018.Late infection in cementless tha, 3 years after primary operation.Infection is a known possible adverse event following every surgery, including tha's.To date, there is no reason to suspect that the cause may be linked to the implanted devices.
Event or Problem Description
Revision surgery due to infection with propioni bacteria 3 years after primary.

• Brand Name: ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7446809
• Report Number: 3005180920-2018-00252
• Device Sequence Number: 16573577
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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: 02/29/2020
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 150073
• 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: 03/22/2018
• Initial Report FDA Received Date: 04/20/2018
• 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: 54 YR