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

Model Number	01.12.23SN
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 january 2021: lot 147646: (b)(4) items manufactured and released on 20-feb-2015.Expiration date: 2019-12-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported since 2017.Clinical evaluation performed by medacta medical affairs department on 4 february 2021: femoral component revision surgery performed 3 years and 2 months after cementless total hip arthroplasty in an elderly lady ((b)(6) year old).No information concerning patient general health status and presence of comorbidities is available.According to the report, the stem subsided but this cannot be properly assessed in a single pre-revision poor quality x-ray.The reason of this event cannot be determined.
Event or Problem Description
Revision surgery performed due to stem subsidence 3 years and 2 months after the primary surgery.The surgeon revised the quadra h sn standard size 3 with a minimax stem - size 6 and the head with the same size implant.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 3, SHORT NECK
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11279338
• Report Number: 3005180920-2021-00082
• Device Sequence Number: 11781681
• 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: 2017
• Device Explanted Year: 2021
• 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): 02/04/2021

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: 12/31/2019
• Device Model Number: 01.12.23SN
• Device Catalogue Number: 01.12.23SN
• Device Lot Number: 147646
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/04/2021
• 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: 81 YR