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

Model Number	01.12.033
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 11 september 2020: lot 176720: (b)(4) items manufactured and released on 8-feb-2018.Expiration date: 2023-01-30.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 due to implant mobilization.With 2 similar reported events due to infection.Additional items involved in the event, batch review performed on 11 september 2020: cup: mpact 01.32.158dh acetabular shell ø58 two-holes (k132879) lot.168448 lot 168448: (b)(4) items manufactured and released on 07-mar-2017.Expiration date: 2022-02-23.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: mpact 01.32.3648hct flat pe hc liner ø36/f (k1037219) lot.168473.Lot 168473: (b)(4) items manufactured and released on 07-mar-2017.Expiration date: 2022-02-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 similar reported events.Ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.178804.Lot 178804: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-04-13.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 after 1 year and 5 months from the primary surgery due to femoral stem loosening and infection.All implants have been removed.It is unknown if the infection caused a mobilization or are separate events.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10612477
• Report Number: 3005180920-2020-00660
• Device Sequence Number: 14135614
• Product Code: LZO
• UDI-Device Identifier: 07630030802157
• UDI-Public: 07630030802157
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: 01/30/2023
• Device Model Number: 01.12.033
• Device Catalogue Number: 01.12.033
• Device Lot Number: 176720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• 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: 49 YR