MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 52

Model Number	01.26.45.1152
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	05/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 may 2020: lot 082588: (b)(4) items manufactured and released on 13-oct-2008.Expiration date: 2013-09-30.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 since 1-1-2016.Other device involved in the event: stem: quadra-h 01.12.034 cementless, ha coated lat stem size 4 lot.082238 (k082792).Batch review performed on 25 may 2020: lot 082238: (b)(4) items manufactured and released on 14-0ct-2008.Expiration date: 2013-09-30.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 since 1-1-2016.
Event or Problem Description
Revision surgery for stem and cup loosening about 11 years after primary surgery.Radiolucency was present without a mechanical cause.No infection detected.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d deprtment: visual inspection performed on 15-dec-2020.Except for the signs related to the extraction, no evident signs of loosening were found on the stem.From the received components, it is not possible to determine the root cause of the event,but we can exculde a failure of the device.Clinical evaluation performed by medacta medical affairs deprtment: 11 years after cementless primary tha both femoral and acetabular components are found loose and replaced.The stem appears in varus position but this was the situation also postoperatively in 2009.The cup is in a rarefied bone area, and again this was the case since primary surgery.However, bone quality and conditions have deteriorated over the years, probably creating the loosening conditions.We cannot identify other potential causes or anomalies from the images supplied.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10137533
• Report Number: 3005180920-2020-00322
• Device Sequence Number: 2319041
• Product Code: MEH
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 09/30/2013
• Device Model Number: 01.26.45.1152
• Device Catalogue Number: 01.26.52MB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 01/08/2021
• 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