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

Model Number	01.12.023
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch review performed by medacta regulatory affairs department on 17 june 2020: lot 170871: (b)(4) items manufactured and released on 31-jul-2017.Expiration date: 2022-07-19.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.Other devices involved in the event: cup: versafitcup cc trio 01.26.45.0050 acetabular shell cc trio ø 50 lot.173466 (k103352).Batch review performed by medacta regulatory affairs department on 17 june 2020: lot 173466: (b)(4) items manufactured and released on 19-sep-2017.Expiration date: 2022-09-07.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.Ball heads: cocr 01.25.022 cocr ball head 12/14 ø 32 size m 0 lot.180641 (k072857).A batch review performed by medacta regulatory affairs department on 17 june 2020: lot 180641: (b)(4) items manufactured and released on 30-may-2018.Expiration date: 2023-05-21.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.Liner: cc e cc light 01.26.3244hct flat pe hc liner ø 32 / e lot.171719 (k103352).A batch review performed by medacta regulatory affairs department on 17 june 2020: lot 171719: (b)(4) items manufactured and released on 25-jun-2017.Expiration date: 2022-07-03.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
2nd infection of thr requiring revision surgery to remove all implants after 2 years and 5 months from the primary surgery.The first infection and revision of head and liner was done in (b)(6) 2018.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; CH 6874, CHE
• MDR Report Key: 10257289
• Report Number: 3005180920-2020-00397
• Device Sequence Number: 11534004
• Product Code: LZO
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: No Information
• Device Expiration Date: 07/19/2022
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 170871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/10/2020
• 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: 65 YR
• Patient Weight: 80