MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 50/28

Catalog Number	01.26.2850M
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2017 the medical affairs director performed a clinical evaluation and commented as follows: eight years after primary cementless dm tha the surgeon observed osteolysis around the dm cup and exchanged it.We have evidence neither of the preoperative situation nor of the immediate postoperative.Some particular condition must have induced the surgeon to ream up to a very large size.In the one supplied image the cup protruded medially beyond the lamina quadrilateral, but we do not know if this was the postoperative situation or the result of cup migration.In the poor quality image, osteolysis is hardly identifiable.It is conceivable that after 8 years, particularly with a double mobility cup, some pe particles may be produced; no information is supplied as to age and activity level of this patient.Batch review performed on (b)(6) 2017.Lot 090898: (b)(4) items manufactured and released on 18 august 2009.Expiration date: 2014-04-30.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.
Event or Problem Description
The patient came in complaining of pain.The surgeon determined that patient had osteolysis around the cup.The surgeon removed and replaced the cup and the liner.The surgery was completed successfully.X-rays are available; explants are not available.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 50/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 6847603
• Report Number: 3005180920-2017-00493
• Device Sequence Number: 11117717
• Product Code: MEH
• UDI-Device Identifier: 07630030808067
• UDI-Public: 07630030808067
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: 01.26.2850M
• Device Lot Number: 090898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention