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

Catalog Number	01.12.20SN
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2019: lot 163270: (b)(4) items manufactured and released on 5 july 2016.Expiration date: 2021-06-21.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: 3 years after primary cementless tha the stem is found loose and replaced.The documentation supplied does not represent the pre-revision situation, hence no assessment of this case can be performed with the information at hand.Aseptic loosening of prosthetic components is a possible adverse event following tha, described in literature; causes often remain undetermined.
Event or Problem Description
Revision surgery performed 3 years and 1 month after the primary due to instability caused by a loose stem.The cause of the loose stem is unknown.The surgeon revised the stem, head, and liner.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
• Common Device Name: HIP SEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9510765
• Report Number: 3005180920-2019-01101
• Device Sequence Number: 11282543
• Product Code: JDI
• UDI-Device Identifier: 07630030802607
• UDI-Public: 07630030802607
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/23/2019

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: 06/21/2021
• Device Catalogue Number: 01.12.20SN
• Device Lot Number: 163270
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/23/2019
• 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