MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD, SHORT NECK; CEMENTLESS FEMORAL STEM

Catalog Number	01.12.22SN
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At primary surgery, difficulties found in femur exposure and femur canal finding.Additional information received on 25 july 2017 and includes: the surgeon added 2 screws to secure the cup more.No wire applied on the femur.Batch review performed on 17 august 2017.Lot 168402: (b)(4)items manufactured nad released on 12 april 2017.Expiration date 2022-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without ay similar reported event.On 17 august 2017 the medical affairs performed a clinical evaluation and commented as follows: early postoperative femoral fracture in cementless tha on a (b)(6)-year old woman.The origin of the fracture, most likely generated intraoperatively, should probably be sought in the difficult and peculiar anatomy of the patient, which made it difficult to find the strongly bowed femoral canal.Intraoperative fractures are a possible, literature-described complication of the tha operation; a peculiar and difficult anatomy makes the odds of such an event obviously higher.
Event or Problem Description
After primary surgery, it was noticed that the femur had been fractured: stem, head and liner revised in amis approach on the following day with items of the same references.Moreover, the surgeon added 2 screws to secure the cup more.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 2 STD, SHORT NECK
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6800232
• Report Number: 3005180920-2017-00449
• Device Sequence Number: 10895548
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: 04/02/2022
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 168402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/17/2017
• 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: 75 YR