MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE1; FEMORAL STEM

Model Number 01.12.021

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Inadequate Osseointegration (2646)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 april 2021: lot 073152: (b)(4) items manufactured and released on 04-feb-2008.Expiration date: 2012-12-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.Clinical evaluation performed by medacta medical affairs department: hip revision surgery performed 13 years after cementless double-mobility total hip arthroplasty.The pre-revision xrays show a proximal femur significantly osteoporotic but this may be the result of osteolytic activity that could have been triggered by polyethylene wear over the thirteen years of active service of this implant.10 years of active service corresponds to what many literature articles describe as the life expectancy of a standard pe insert.Analysis of the explanted liner could indicate if abnormal wear took place.Another device involved: batch review performed on 06.05.2021: liner: versafitcup dm 01.26.2850m double mobility liner ø 50/28 (k083116), lot 080524: (b)(4) items manufactured and released on 03-apr-2008.Expiration date: 2013-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.

Event Description

Revision surgery performed due to stem loosening 12 years 10 months after the primary.Stem, head, and liner successfully revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE1
• Type of Device: FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11784064
• MDR Text Key: 257541607
• Report Number: 3005180920-2021-00353
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Device Lot Number: 073152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 68