MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number	01.12.032
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 august 2019.Lot 115213: (b)(4) items manufactured and released on 17-feb-2012.Expiration date: 2017-01-31.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.Clinical evaluation performed by medical affairs director.Femoral component revision surgery performed 4,5 years after cementless total hip arthroplasty in a (b)(6) woman.In the radiographic image provided, radiolucent lines in gruen zones 1 and 7 and signs of stress shielding are visible.The stem looks slightly undersized and probably subsided.The reason of this choice cannot be assessed on the basis of a single pre-revision anteroposterior radiographic projection.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery performed, 4 years and 8 months after primary surgery, due to pain caused by loosening of the femoral stem.The revision surgery was performed anteriorly.The quadra stem was removed using the explant instrument and osteotomes.The stem was bonded at the tip but the surgeon informed told that it was loose proximally.The surgeon then broached the bone with minimax broaches and implanted a size 3 left minimax stem, with a 32 m ceramic head.Bone graft was also used in the femoral canal.Also the head was revised.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9097884
• Report Number: 3005180920-2019-00787
• Device Sequence Number: 14143963
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 01.12.032
• Device Lot Number: 115213
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/20/2019
• 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
• Patient Age: 56 YR