MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø54 TWO-HOLES

Catalog Number 01.32.054DH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Joint Disorder (2373)

Event Date 11/14/2016

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on 13 december 2016.Lot 115132: (b)(4) items manufactured and released on 01 june 2012.Expiration date: 2017-04-30.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.Mpact flat pe hc liner ø36/f, code 01.32.3648hct, lot.130418 (k103721) (b)(4) items manufactured and released on 08 march 2013.Expiration date: 2018-01-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0, code 01.29.209, lot.130324 (k112115) (b)(4) items manufactured and released on 05 april 2013.Expiration date: 2018-02-28.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 Description

The patient came in complaining of a difference in limb length.The surgeon revised the cup, head and liner.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Type of Device: ACETABULAR SHELL
• 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: 6173744
• MDR Text Key: 62356206
• Report Number: 3005180920-2016-00653
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103721
• 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: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 01.32.054DH
• Device Lot Number: 115132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2012
• 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: 51 YR