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

Model Number	01.12.021
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11784064
• Report Number: 3005180920-2021-00353
• Device Sequence Number: 3659846
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 05/06/2021

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 05/06/2021
• 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: 84 YR
• Patient Weight: 68