MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 3 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.133

Device Problem Misconnection (1399)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information received on 02 march 2017 and includes: the medacta device wouldn't pull the stem out, so the surgeon had no other option but to use a non-medacta product.Batch review performed on 28 february 2017.Lot 157489: (b)(4) items manufactured and released on 06 april 2016.Expiration date: 2021-03-23.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.Device not yet received.

Event Description

During surgery the stem would not seat properly.The surgeon used a stem extractor (non-medacta product) to remove the stem, but the stem became damaged upon removal.The surgeon used a secondary stem to complete the surgery.There was no significant delay in surgery.The surgery was completed successfully.X-rays are not available; damaged stem and instrumentation are available.

Manufacturer Narrative

Not yet analyzed.

Manufacturer Narrative

On (b)(6) 2017 the r&d joint replacement director performed a visual inspection of the received explants and commented as follows: one of our representative was assisting this surgery and he noticed that the discrepancy between the broach and the stem was probably due to the fact that the final broach was very tight against the cortical bone.A broach of one size less would have be more adequate.In this situation the probability to increase the position discrepancy between broach and stem is higher because the stem has an ha coating of 80 microns that protrude on each side from the stem that give to the stem the tendency of protruding as soon is touching the cortical bone.To compensate this mismatch the surgeon impacted the stem quite heavy, blocking it in the canal.The plastic repositioning device is not adequate to remove such a blocked stem.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 3 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: 6376262
• MDR Text Key: 69018523
• Report Number: 3005180920-2017-00086
• 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,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2021
• Device Catalogue Number: 01.18.133
• Device Lot Number: 157489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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