MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK; CEMENTLESS HIP STEM

Catalog Number	01.12.23SN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 january 2019: lot 181780: (b)(4) items manufactured and released on 17 july 2018.Expiration date: 2023-07-02.No anomalies found related to the issue.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 28 size m 0 reference 01.29.202 (k112115).Lot 176811: (b)(4) items manufactured and released on 09 april 2018.Expiration date: 2023-03-22.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Versafitcup dm double mobility hc liner ø 54/28 reference 01.26.2854mhc (k092265).Lot 176082: (b)(4) items manufactured and released on 21 december 2017.Expiration date: 2022-12-04.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
One week after primary for an infection case the surgeon performed an i&d and revised successfully the stem, the head and the liner.The pathogen was identified as streptococcus.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, 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: 8217200
• Report Number: 3005180920-2018-01059
• Device Sequence Number: 16551936
• Product Code: JDI
• UDI-Device Identifier: 07630030802638
• UDI-Public: 07630030802638
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 07/02/2023
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 181780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2023
• Initial Report FDA Received Date: 01/04/2019
• 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: 55 YR