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

Catalog Number	01.12.34SN
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2019: lot 168413: (b)(4) items manufactured and released on 01-mar-2017.Expiration date: 2022-02-21.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 performed by medical affairs manager: femoral component revision occurred 1 year and 7 months after cementless total hip arthroplasty in a young ((b)(6) year old) heavy ((b)(6) kg) man.In the radiographic image provided the stem looks probably subsided but this cannot be confirmed not having an immediate postoperative x-ray.One hypothesis could be undersizing but this cannot be assessed on the basis of a single anteroposterior pre-revision x-ray.No conclusion can be drawn.
Event or Problem Description
On (b)(4) 2019 we were informed about a revision surgery performed on (b)(6) 2019, 1.5 years after primary surgery, due to stem loosening.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4, SHORT NECK
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8649832
• Report Number: 3005180920-2019-00415
• Device Sequence Number: 13998885
• Product Code: LZO
• UDI-Device Identifier: 07630030802744
• UDI-Public: 07630030802744
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2022
• Device Catalogue Number: 01.12.34SN
• Device Lot Number: 168413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/29/2019
• 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: 51 YR
• Patient Weight: 110