MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.39.203
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 november 2019: lot 180817: 15 items manufactured and released on 20-jun-2018.Expiration date: 2023-06-10.No anomalies found related to the problem.To date, 14 items of the same lot have been already sold without any similar reported event.Additional devices involved: batch reviews performed on 05 november 2019: versafitcup cc trio 01.26.45.0050 acetabular shell cc trio ø 50 (k103352) lot 183942: 160 items manufactured and released on 13-sept-2018.Expiration date: 2023-09-02.No anomalies found related to the problem.To date, 156 items of the same lot have been already sold without any similar reported event.Other: screws 01.26.65.30 cancellous bone screw flat head ø 6,5 l 30 (k103352) lot 175094: 110 items manufactured and released on 13-sept-2017.Expiration date: 2022-08-30.No anomalies found related to the problem.To date, 102 items of the same lot have been already sold without any similar reported event.Ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 ø 36 size l + 4 (k112115) lot 177708: 120 items manufactured and released on 05-mar-2018.Expiration date: 2023-02-22.No anomalies found related to the problem.To date, 112 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medacta medical affairs manager: delayed infection in cementless tha, 9 months 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.Visual inspection performed by medacta hip r&d project manager: signs of bone residual on the stem, scratches on the femoral neck due to extraction, removal residuals also on liner and femoral head.
Event or Problem Description
The surgeon performed a revision surgery 9 months after primary for infection (acnes bacterium).Stem, ceramic liner, ceramic head and screw revised successfully.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection: signs of bone residual on the stem, scratches on the femoral neck due to extraction, removal residuals also on liner and femoral head.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9383332
• Report Number: 3005180920-2019-00994
• Device Sequence Number: 469619
• Product Code: LZO
• UDI-Device Identifier: 07630030885631
• UDI-Public: 07630030885631
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 06/10/2023
• Device Catalogue Number: 01.39.203
• Device Lot Number: 180817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: 72 YR