MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY LINER 54/28; HIP SHELL LINER

Model Number	01.26.2854M
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2021: lot 110796: (b)(4) items manufactured and released on 10-jun-2011.Expiration date: 2016-04-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional devices involved.Batch reviews performed on 25 may 2021: cup: versafitcup 01.26.54mb acetabular shell ø 54 (k083116) lot 111513: (b)(4) items manufactured and released on 06-jul-2011.Expiration date: 2016-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Stem: quadra-h 01.12.025 cementless, ha coated std stem size 5 (k082792) lot 111885: (b)(4) items manufactured and released on 07-oct-2011.Expiration date: 2016-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medacta medical director: 9 years after primary tha with double mobility cup a revision is necessary, according to the report because of osteolysis due to wear debris of the polyethylene insert.The patient was active (primary diagnosis: fracture) and therefore the presence of wear of a standard polyethylene insert after 9 years is not exceptional.The stem was still well fixed, this probably means that for specific fluidodynamic reasons the wear debris concentrated on the pelvic bone and gave rise to macrophagic reaction.If possible, the explanted devices could be analyzed to detmine if third-bodytraces are visible: the presence of a third body in the articulation may have accelerated the wear process.Visual inspection performed by medacta r&d hip project manager: from the received pieces it was observed visible yellowing and opacity on the external surface of the liner.Some little scratches were also noticed on the surface, probably occurred for the presence of a third body; also on the inner surface of the shell some small signs were noticed: also in this case their presence can be related to a third body.Finally, on the rim of the shell, some damages are present, probably occurred during the extraction.From the received piece it is not possible to determine with certainty the root cause of the event, but we cannot exclude the presence of a third body; in addition, these types of events are not rare in standard polyethylene liners.
Event or Problem Description
Left hip revision performed on (b)(6) 2021 (9 years and 2 months after primary) following suspected polyethylene wear and acute osteolysis (paprosky stage 2) of the acetabulum and the femoral proximal part.Only the liner, the cup versaficup, and the inox head have been removed, the quadra stem was left in place.The revision went well.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY LINER 54/28
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11893141
• Report Number: 3005180920-2021-00422
• Device Sequence Number: 1295275
• Product Code: MEH
• UDI-Device Identifier: 07630030807374
• UDI-Public: 07630030807374
• 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: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: 04/30/2016
• Device Model Number: 01.26.2854M
• Device Catalogue Number: 01.26.2854M
• Device Lot Number: 110796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/27/2021
• 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: 73 YR