MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 52/28

Catalog Number 01.26.2852M

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 02/26/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 march 2018 (b)(4).Clinical evaluation performed by medical affairs director on 27 march 2018.Hip revision surgery occurred 8 years after primary dm tha.Pictures provided show the presence of a foreign body in the polyethylene double mobility liner.The nature and origin of this object cannot be determined on the basis of information available.The potential role that this finding may have had in the generation of pain is unknown.According to report, components from two different manufacturers were used in the assembly.The coupling of parts that were not designed to be assembled may have unpredictable consequences, but there are not enough elements to analyse potential influence of this situation.Preliminary investigation performed on 28 march 2018 by r and d product manager: from the images we cannot define which material is included in the hole of the liner.Usually, coagulated residual blood can be noted in such a hole.The radiographic images do not show evidence of metallic debris.Different slices could confirm the absence of metallic debris in the hole.Anyway, the external surface of the liner is damaged: that was probably caused by a third external body.

Event Description

The patient came in complaining of pain and clicking of the hip 8 years after primary.Upon removal of the liner the surgeon noticed a black dot on the outside top of the liner.The visible black dot on the outside of the liner extended through the entire liner.When the surgeon cracked it open, a piece of it came out.It was not a blood clot.There was visible wear at the apex of the inside of the liner which was a yellowish color and the rest of the liner was white.The surgeon implanted a medacta liner with another company's head.The surgery was completed successfully.The agent reported that surgeon said it sounded like trunnionosis.Especially due to the fact the head and stem were mismatched companies.Note: another company's stem used in primary.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 52/28
• Type of Device: DOUBLE MOBILITY LINER
• 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
• MDR Report Key: 7377661
• MDR Text Key: 103700563
• Report Number: 3005180920-2018-00186
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807336
• UDI-Public: 07630030807336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 01.26.2852M
• Device Lot Number: 092654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2009
• 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