MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 6 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.136

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on 27 december 2016.Lot 130604: (b)(4) items manufactured and released on 02 may 2013.Expiration date: 2018-03-31.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.Versafitcup acetabular shell diam 58, code 01.26.58mb, lot.133457 (k083116), (b)(4) items manufactured and released on 18 october 2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold and this is the second similar event reported on the same lot.Mectacer biolox delta ceramic ball head 12/14 ø 28 size s -3.5, code 01.29.201, lot.132943 (k112115), (b)(4) items manufactured and released on 10 september 2013.Expiration date: 2018-07-31.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.Double mobility hc liner diam 58/28, code 01.26.2858mhc, lot.131723 (k092265), (b)(4) items manufactured and released on 12 june 2013.Expiration date: 2018-04-30.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.Additional information received on 29 december 2016 and includes: the patient has not rescheduled a revision surgery yet.It will be early in 2017.Device not yet explanted.

Event Description

The patient came in complaining of pain.The surgeon determined the patient has an infection.The infection is confirmed.The surgeon plans to revise all medacta components and implant an antibiotic spacer.A revision is not scheduled yet.

Manufacturer Narrative

The surgeon planned to revise all medacta components and implant an antibiotic spacer but a revision surgery had not been planned, yet.To date, medacta has not received any information related to the revision surgery.For this reason, the complaint is closed.In case of receiving any update about this case, it will be communicated to fda.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 6 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: 6215349
• MDR Text Key: 63616147
• Report Number: 3005180920-2016-00690
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 01.18.136
• Device Lot Number: 130604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2013
• 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