MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 6; CEMENTLESS HIP STEM

Catalog Number	01.12.006
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 september 2019: lot 071205: 14 items manufactured and released on 06-jul-2007.Expiration date: 2012-05-31.No anomalies found related to the problem.To date, 12 items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director.Hip revision surgery performed 10 years after cementless double-mobility total hip arthroplasty.The pre-revision xray shows a proximal femur significantly osteoporotic - but this may be the result of osteolytic activity that could have been triggered by polyethylene wear over the ten 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.The low quality xray image does not allow even a tentative wear evaluation.Analysis of the explanted liner could indicate if abnormal wear took place.Preliminary investigation performed by r&d project manager.Preliminary investigation performed on (b)(6) 2019.From the received image it is not possible to determine the root cause of the event: the image shows the double mobility liner just explanted.Further analysis can be performed once received the parts.
Event or Problem Description
Revision surgery performed after 10 years and 2 months from the primary due to pain caused by a loose stem.The surgeon revised the stem, head and liner successfully.The reason for loosening is unknown.

• Brand Name: STEM: QUADRA-S CEMENTLESS, SAND BLASTED STD STEM SIZE 6
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9201324
• Report Number: 3005180920-2019-00867
• Device Sequence Number: 11539937
• Product Code: JDI
• UDI-Device Identifier: 07630030801877
• UDI-Public: 07630030801877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 05/31/2012
• Device Catalogue Number: 01.12.006
• Device Lot Number: 071205
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/17/2019
• 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