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

Model Number	01.12.025
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 march 2020: lot 182662: (b)(4) items manufactured and released on 29-aug-2018.Expiration date: 2023-08-20.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.Additional implant involved: cup: versafitcup cc trio 01.26.45.0054 acetabular shell cc trio 54 (k103352) lot.180907 batch review performed on 18 march 2020: lot 180907: (b)(4) items manufactured and released on 30-apr-2018.Expiration date: 2023-04-19.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.Additional implant involved: ball heads: mectacer 01.29.210 biolox delta ceramic ball head 12/14 36 size l + 4 (k112115) lot.183363 batch review performed on 18 march 2020: lot 183363: (b)(4) items manufactured and released on 12-sep-2018.Expiration date: 2023-08-30.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.Additional implant involved: liner: cc e cc light 01.26.3644hct flat pe hc liner 36 / e (k103352) lot.181716.Batch review performed on 18 march 2020: lot 181716: (b)(4) items manufactured and released on 13-jun-2018.Expiration date: 2023-05-28.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.
Event or Problem Description
Revision surgery performed 1 year and 4 months after primary surgery due to infection.All implants successfully revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9847173
• Report Number: 3005180920-2020-00167
• Device Sequence Number: 16329404
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 08/20/2023
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 182662
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/18/2020
• 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
• Patient Weight: 118