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

Catalog Number	01.26.2848M
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 may 2019: lot 090083: (b)(4) items manufactured and released on 30-mar-2009.Expiration date: 2014-02-28.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any other similar reported event.Additional implant involved in the event ball heads: mectacer 38.39.7175.245.00 biolox forte ceramic ball head 12/14 ø 28 size s -3.5 (usa) (k073337).Lot: 082881: (b)(4) items manufactured and released on 24-oct-2008.Expiration date: 2013-08-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any other similar reported event.Visual inspection performed by r&d project manager: visual inspection shows deformation of the inner sphericity of the pe liner, causing inner head rom reduction and non congruent relative movement between the two components.The pe liner edge shows some deformation too.It is not possible to determine failure root cause.
Event or Problem Description
Revision surgery about 9 years and 10 months after primary due to generic pain.The reason of pain is unknown.Cup and stem looked well fixed.The surgery was completed successfully, head and liner swapped successfully.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28
• Common Device Name: HIP DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8636448
• Report Number: 3005180920-2019-00401
• Device Sequence Number: 1858421
• Product Code: MEH
• UDI-Device Identifier: 07630030807237
• UDI-Public: 07630030807237
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2019

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: 02/28/2014
• Device Catalogue Number: 01.26.2848M
• Device Lot Number: 090083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/23/2019
• 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