MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 STD, SHORT NECK; CEMENTLESS FEMORAL STEM

Catalog Number 01.12.25SN

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Batch reviews performed on 30 january 2017.Lot 151871: (b)(4) items manufactured and released on 06 july 2015.Expiration date: 2020-05-31.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.Quadra-h cementless, ha coated stem size 4 std, short neck, code 01.12.24sn, lot.146382 (k093944) (b)(4) items manufactured and released on 08 january 2015.Expiration date: 2019-11-30.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.Not yet received.

Event Description

The surgeon wasted 2 stems and a ceramic head during a primary bilateral total hip.When the surgeon implanted the stem, it sat higher than the broach.The stem sat approximately 8mm to 1cm too high on both the left and right hip.The surgeon removed the stem, rebroached, and implanted a new stem on both the left and right hip.This caused about a 10 minute delay in surgery.The surgery was completed successfully.The implant will be available for investigation.

Manufacturer Narrative

Additional information received on 03 february 2017 and includes: it was confirmed that the products are not available for further investigations (on the contrary of what previously reported in the initial report).

• Brand Name: QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 STD, SHORT NECK
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 6296391
• MDR Text Key: 66765037
• Report Number: 3005180920-2017-00009
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 01.12.25SN
• Device Lot Number: 151871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 02/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR