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

Model Number	01.12.023
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 february 2021: lot 100768: (b)(4) items manufactured and released on 31-may-2010.Expiration date: 2015-04-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event since 2017.Clinical evaluation performed by medacta medical affairs director: 8 years after primary cementless tha the hip is painful and gets revised.The single xray image provided shows extensive radiolucency along the proximal part of the stem, gruen zones 1, 2, 6, 7.The bone quality in the trochanteric region appears very poor.A second projection could have helped decyphering anterior and posterior proximal stem coverage, which is unclear.The report does not mention infection or systemic problems, although the images are also compatible with such a situation.No final conclusion can be drawn on this case.Preliminary investigation performed by medacta hip r&d project manager: looking at the images attached to the complaint is it possible to see that part of the proximal part of the stem is ha coated, meaning that in this area the osteointegration failed.In the other part of the stem body the ha has been completely absorbed by the bone, as expected.There are images also on the explanted cups.There are a lot of scratches on the cup surface and liner maybe created during the revision surgery.It is not possible to determine the root cause of the loosening.
Event or Problem Description
Stem revised 8 years after primary due to aseptic loosening.Primary surgery was in 2013, exact date is unknown.Also ceramic liner, ceramic head and cup have been revised (ref and lots unknown).

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11377941
• Report Number: 3005180920-2021-00149
• Device Sequence Number: 3631069
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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 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): 02/25/2021

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: 04/30/2015
• Device Model Number: 01.12.023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 100768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/25/2021
• 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