MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.25SN
Health Effect - Clinical Codes	Hip Fracture (2349); Joint Disorder (2373)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2018.Lot 166565: 30 items manufactured and released on 13 february 2017.Expiration date: 2022-02-02.No anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.Others devices involved: mpact dm double mobility hc liner ø 52/28 reference 01.26.2852mhc (k092265).Lot 177528: 110 items manufactured and released on 20 february 2018.Expiration date: 2023-02-04.No anomalies found related to the problem.To date, 56 items of the same lot have been already sold without any similar reported event.Mpact double mobility acetabular shell ø52 reference 01.32.152mb (k143453).Lot 176647: 39 items manufactured and released on 18 january 2018 expiration date: 2023-01-09.No anomalies found related to the problem.To date, 26 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Three days after primary the surgeon revised the stem, the head and the liner for a hip dislocation and femur fracture.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7536826
• Report Number: 3005180920-2018-00350
• Device Sequence Number: 2481946
• Product Code: LZO
• UDI-Device Identifier: 07630030802652
• UDI-Public: 07630030802652
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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: 02/02/2022
• Device Catalogue Number: 01.12.25SN
• Device Lot Number: 166565
• 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: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• 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