MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA -R 01.12.062 CEMENTLESS, HA COATED REVISION STEM SIZE 2; HIP COATED REVISION STEM

Model Number	01.12.062
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a subsided stem and the cause is unknown.About 2 months and a half, the surgeon revised the stem, head, and liner.The surgery was completed successfully.Implanted stem: 01.22.730 monoblock stem ø21mm l 240mm lat.
Additional Manufacturer Narrative
Batch review performed on 16 november 2022.Lot: 1901722: (b)(4) items manufactured and released on 05-jul-2019.Expiration date: 2024-jun-22.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision performed 2 and a half months after cementless total hip arthroplasty.According to report, the revision was necessary due to stem subsidence.The patient's condition before being re-operated cannot be determined since no pre-revision images are provided.Intra-op images show the monoblock stem inserted and a cerclage, presumably to prevent intra-op fractures.The subsidence may happened secondary to aseptic loosening.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.No definite cause could be determined for this adverse event.

• Brand Name: STEM: QUADRA -R 01.12.062 CEMENTLESS, HA COATED REVISION STEM SIZE 2
• Common Device Name: HIP COATED REVISION STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15977589
• Report Number: 3005180920-2022-00910
• Device Sequence Number: 6997504
• Product Code: JDI
• UDI-Device Identifier: 07630030802409
• UDI-Public: 07630030802409
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: 06/22/2024
• Device Model Number: 01.12.062
• Device Catalogue Number: 01.12.062
• Device Lot Number: 1901722
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male