MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0; CEMENTLESS HIP STEM

Catalog Number	01.12.020
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Preliminary investigation performed by r&d product manager on 04 september 2018: stem hydroxyapatite layer has been absorbed, stem does not show of removal procedure or residual bone, indicating easy extraction.Metal transfer scratch on the femoral head.Acetabular cup, extracted with bone residual, does not show particular signs.From preliminary investigation, it is not possible to determine failure root cause.Batch review performed on 13 september 2018.Lot 113020: (b)(4).Expiration date: 2016-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on 14 september 2018: total hip revision surgery occurred 4 years after primary cementless arthroplasty in a (b)(6) woman.Radiographic image provided shows the presence of radiolucent lines around the stem that slightly subsided in the femoral canal.Aseptic loosening is a possible literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
We were informed on (b)(6) 2018 that patient has presented with hip pain to surgeon.Arthrogram shows dye travelling down one third of stem indicating asceptic loosening.Revision surgery booked for (b)(6) 2018.Post revision info received on the 30th august 2018: cup was well fixed, but he wasn't happy with the inclination, feeling it was too open.When he removed it, some bone come with it, so he ended up using a competitor cup and synthetic bone graft (i had left by that stage).The stem was loose and came out easily using the sword.Had about 2-3mm of toggle prior to using the removal tools.The head had some scratches on the surface and some wear inside.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7876583
• Report Number: 3005180920-2018-00680
• Device Sequence Number: 11317204
• Product Code: JDI
• UDI-Device Identifier: 07630030802010
• UDI-Public: 07630030802010
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 09/30/2016
• Device Catalogue Number: 01.12.020
• Device Lot Number: 113020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/14/2018
• 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 Weight: 80