MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5; CEMENTLESS HIP STEM

Model Number	01.12.035
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 august 2021 lot 092857: (b)(4) items manufactured and released on 08-march-2010.Expiration date: 2015-01-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event on this lot since 2017.Clinical evaluation performed by medical affairs director.Ten years after primary cementless tha in a rather heavy male patient the stem gets loose and needs revision.The quality of the xray images available does not allow precise evaluation of the radiological situation, but no macroscopical anomalies are visible.Aseptic loosening is a possible adverse event following tha, described in literature, and its probability increases with time.No further conclusion can be drawn to date with the information at hand.Preliminary investigation performed by r&d project manager.Looking at the images attached to the complaint it is visible the expianted stem with some bloods residuals on the whole body.The ha coating on the stem body has been completely absorbed by patient bone as expected.Some signs and scratches are present on the neck surface due to revision surgery.In the images are visbile also expianted pe liner and femoral head.It is not possible to determine the root cause of reported patient pain and loosening of expianted stem.
Event or Problem Description
10 years 4 months after the primary the patient came in reporting pain due to stem loosening.Stem, head and liner successfully revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12539777
• Report Number: 3005180920-2021-00775
• Device Sequence Number: 17169463
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• 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: 2011
• 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): 09/28/2021

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: 01/31/2015
• Device Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 092857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/28/2021
• 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: 78 YR
• Patient Weight: 100