MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H CEMENTLESS STEM; FEMORAL CEMENTLESS STEM

Catalog Number	01.12.25SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional details received on (b)(6) 2017: revision of a total hip implanted on (b)(6) 2014; pain for more than 1 year with a suspect loosening of the femoral stem after a fall.The amistem c cemented stem size 2 was extracted without difficulties and replaced with the quadra short neck cementless stem., on (b)(6) 2017.At the post-op control, the surgeon saw a fracture and re-operated the patient on (b)(6) 2017 using 3 wires for the fracture, without explanting any device.On (b)(6) 2018 the medical affairs director: a cemented femoral stem in tha got loose after a few years probably because of a traumatic event.During revision surgery, a fissure was created on the femur.This is a known, possible adverse event that may take place during femoral preparation, known and quantified in literature.It is more likely to happen in a revision case where the femoral bone is already weakened.No reason to suspect a faulty implant.Batch review performed on (b)(6) 2018.Lot 164567: (b)(4) items manufactured and released on (b)(6) 2015.Expiration date: 2021-10-10.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.
Event or Problem Description
Three days after the stem revision the surgeon detected a femur fracture and revised the patient a second time applying three cerclage.No implants swap.The surgery was completed successfully.

• Brand Name: QUADRA H CEMENTLESS STEM
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7206125
• Report Number: 3005180920-2017-00860
• Device Sequence Number: 13666457
• Product Code: LZO
• UDI-Device Identifier: 07630030802652
• UDI-Public: 07630030802652
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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: 10/10/2021
• Device Catalogue Number: 01.12.25SN
• Device Lot Number: 164567
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/19/2018
• 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: 72 YR
• Patient Weight: 75