MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28

Catalog Number	01.26.2848M
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 august 2018.Lot 147751: (b)(4) items manufactured and released on 19 january 2015 expiration date: 2019-11-30 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.Clinical evaluation performed by medical affairs director: premature liner wear in a double mobility cemented cup 3 years after implantation.Index surgery was a revision thr for recurrent dislocation.The significant osteolysis visible in the proximal femur could be a consequence to the macroscopic wear.The cause for wear cannot be determined with the available information; one possible hypothesis is the secondary presence of cement particles in the articulation.Component analysis may supply further information.
Event or Problem Description
The patient complained hip pain 3 years after the previous surgery.The surgeon revised successfully the liner and the head.A premature liner wear and deformation was detected.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager on 20 september 2018 the dual-mobility pe liner shows important material erosion with respect to the original shape.The pe loss seems due to third body wear or to repeated contact and friction with abnormal third body.Few light shining debris are visible inside the scratches in the pe liner, when exposed to bright light.Microscopic analysis reveals black particles on the pe liner outer surface.It might be assumed that these are metal debris.No other debris of other nature were found on the liner.Femoral head shows few metal-transfer signs and huge metal-transfer area.It is not possible to determine failure root cause.At the time of revision surgeon reports no metallosis in the patient and a perfect status of shell and stem.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
• Common Device Name: DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7793272
• Report Number: 3005180920-2018-00620
• Device Sequence Number: 1249392
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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: 11/30/2019
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 147751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 78