MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.12.024
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2018.Lot 155091: (b)(4) items manufactured and released on 23 november 2015.Expiration date: 2020-11-07.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.Preliminary investigation performed by r&d product manager on november 21, 2018.From preliminary visual investigation, it is not possible to determine an implant-related root cause.Images show femoral stem covered by biological fluids.Clinical evaluation performed by medical affairs director on december 12, 2018.Proximal stem loosening in a cementless primary tha after 2.5 years.The radiograph shows a stem slightly in valgus position and with strong distal cortical contact, but we cannot draw any conclusion as to the relevance of these observations to the loosening event.Aseptic loosening is a possible adverse event connected with tha, described in literature.We have no reason to suspect a faulty implant in this case.
Event or Problem Description
Revision surgery due to stem loosening 2 years and 6 months after the primary.The stem was loose at his proximal part, the distal part was well integrated.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8155014
• Report Number: 3005180920-2018-00984
• Device Sequence Number: 19275284
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• 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: 2016
• 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): 12/12/2018

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: 11/07/2020
• Device Catalogue Number: 01.12.024
• Device Lot Number: 155091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/12/2018
• 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 Age: 63 YR
• Patient Weight: 85