MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED, HA COATED STEM SIZE 2 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.232

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Joint Disorder (2373)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 the medical affairs director performed a clinical evaluation and commented as follows: 1 year after primary cementless tha in a rather young male patient the femoral stem is found clinically and radiographically loose.The femoral shape is a typical dorr type-a, known to be difficult to treat with straight cementless femoral stems.The double mobility cup was found to be stable and therefore the surgeon used a compatible medacta liner coupled with a non-medacta head: given the circumstances, this was most probably the best compromise for the patient and it is very unlikely that it may give rise to unwanted clinical consequences.The root cause for this situation cannot be determined with certainty.Batch review performed on 27 december 2016.Lot 153991: (b)(4) items manufactured and released on 06 october 2015.Expiration date: 2020-09-20.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 Description

The patient came in due to feeling unstable.The surgeon determined that the stem was loose.The surgeon revised the stem, head and liner.The surgeon implanted another company's stem and head with a medacta liner.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: AMISTEM COLLARED, HA COATED STEM SIZE 2 STD
• 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: 6208284
• MDR Text Key: 63383567
• Report Number: 3005180920-2016-00681
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: 01.18.232
• Device Lot Number: 153991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2015
• 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): Required Intervention
• Patient Age: 56 YR