MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1; FEMORAL CEMENTLESS STEM

Model Number 01.12.021

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2021: lot 141745: (b)(4) items manufactured and released on (b)(6) 2014.Expiration date: 2019-05-30.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 on this lot since 2017.Preliminary investigation perforemd by medacta r&d department: looking at the images provided of the expianted stem it is visible that almost the whole ha coating has been absorbed by the patient bone as expected.A lot of signs and scratches are present on the neck and taper parts but is reasonably possible that they were created during the revision surgery.It is not possible to hypothesize a defined root cause.Clinical evaluation performed by medacta medical affaris department: 3 years after primary cementless tha the stem is loose and needs revision.It appears to be completely demarcated by radiolucent lines all around, although there is no mention of possible infections.Therefore we must categorize this event as an aseptic loosening, although the radiographical appearance is rather peculiar.No final conclusion can be reached; aseptic loosening is a possible adverse event following tha, reported in literature, though the length of follow up (rather short) and the visual appearance make this case quite particular.

Event Description

Revision surgery performed due to aseptic stem loosening 2 years 11 months after the primary.The surgeon revised the stem, head and liner.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE 1
• Type of Device: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11473933
• MDR Text Key: 239731568
• Report Number: 3005180920-2021-00196
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 141745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention