MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA DOUBLE MOBILITY PE LINER 50/28

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Batch review performed on (b)(6) 2015.Lot 092226: (b)(6) liners manufactured and released on (b)(6) 2009.No anomalies found related to the problem.To date, 29 items of the lot have been already sold without any similar issue reported.On (b)(6) 2015 the medical affairs director made the following analysis: there is no documentation.We do not know which stem was used, it was only referred to us that a non-medacta stem was coupled with the medacta versafit double mobility cup.All medacta stems have a polished neck to reduce the effect of abrasion against a double mobility liner.The geometry of medacta double mobility liners has been designed to match neck angles and so limit point-contact situations.Using a non-medacta product these features are lost and the consequences are unk.It is in fact possible that excessive wear was generated as a consequence of this choice, but we do not have the elements to state so.

Manufacturer Narrative

On 03 august 2015 a final report was prepared with the information already reported into the initial report.On 26 august 2015, the final report was sent to the initial reporter and the case was closed.

• Brand Name: DOUBLE MOBILITY PE LINER 50/28
• Type of Device: PE LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; strada regina; castel san pietro 6874 ; SZ 6874 ; 8782381
• MDR Report Key: 4782521
• MDR Text Key: 5801012
• Report Number: 3005180920-2015-00095
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1