MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6; CEMENTLESS HIP STEM

Model Number	01.12.036
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-jan-2020: lot 080897: (b)(4) items manufactured and released on 07-may-2008.Expiration date: 31-mar-2013.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 2015.
Event or Problem Description
Revision surgery will be performed in (b)(6) 2020 due to stem loosening.
Additional Manufacturer Narrative
Clinical evalaution: partial hip revision surgery perfomed 12 years after cementless total hip arthroplasty in a young (52 year old at time of primary implantation) heavy (105 kg) patient.In the radiographic images provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described long term adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Preliminary investigation: based on the pictures received we can state no more than the implant is covered with small ha residuals.
Event or Problem Description
The revision surgery went on successfully on (b)(6) 2020.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9580421
• Report Number: 3005180920-2019-01140
• Device Sequence Number: 18955468
• Product Code: JDI
• UDI-Device Identifier: 07630030802188
• UDI-Public: 07630030802188
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 03/31/2013
• Device Model Number: 01.12.036
• Device Catalogue Number: 01.12.036
• Device Lot Number: 080897
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/07/2020
• 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: 63 YR
• Patient Weight: 105