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

Model Number	01.12.021
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11473933
• Report Number: 3005180920-2021-00196
• Device Sequence Number: 11682197
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• 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: 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): 03/12/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/12/2021
• 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