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

Catalog Number	01.12.33SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 november 2019: lot 142568: 40 items manufactured and released on 24-jun-2014.Expiration date: 2019-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: 5 years after primary cementless tha in an elderly scoliotic patient the stem is found to be loose, probably also because of an osteolytic reaction (undescribed), visible in the single xray provided, in the proximal femoral region.The cause for this is unknown.Aseptic loosening of implants is a possible failure mode, described in literature, whose causes are often undetermined.No more conclusions can be drawn on this case with the information at hand.
Event or Problem Description
The surgeon informed me that the patient returned with pain on the right side- imaging investigation showed the stem appeared loose.Revision surgery via posterior approach 4 years and 11 months after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection: ha layer absorbed, signs of extraction on femoral neck.It is not possible to determine an implant related failure root cause.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 3, SHORT NECK
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9443535
• Report Number: 3005180920-2019-01046
• Device Sequence Number: 14005819
• Product Code: JDI
• UDI-Device Identifier: 07630030802737
• UDI-Public: 07630030802737
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 05/31/2019
• Device Catalogue Number: 01.12.33SN
• Device Lot Number: 142568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: 80 YR