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

Catalog Number	01.12.024
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 june 2019: lot 091437/t: (b)(4) items manufactured and released on 30 november 2015.Expiration date: 2020-11-10.No anomalies found related to the issue.To date, all the items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery performed, 3 years and 5 months after primary surgery, due to stem loosening.The surgery was completed successfully swapping the patient stem and ceramic ball head.
Additional Manufacturer Narrative
On june 28th 2019 it was confirmed that the primary surgery date is (b)(6), 2016.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8739694
• Report Number: 3005180920-2019-00513
• Device Sequence Number: 19474350
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2019

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: 11/10/2020
• Device Catalogue Number: 01.12.024
• Device Lot Number: 091437/T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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: 47 YR
• Patient Weight: 70