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

Catalog Number	01.12.22SN
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 december 2018: lot 134351: (b)(4) items manufactured and released on 08-nov-2013.Expiration date: 2018-09-30.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.Clinical evaluation performed by medical affairs director: revision surgery occurred 4, 5 years after primary cementless total hip arthroplasty in a (b)(6) year old woman.Radiographic image provided shows the presence of radiotransparent areas in gruen zones 1, 3,4, 5 and 7 probably due to osteolysis or other type of bone reaction.The reason of this event cannot be determined.
Event or Problem Description
The patient came in complaining of pain 4 years and 8 months after the primary.The stem was loose and micro movement had caused heterotopic ossification.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8164773
• Report Number: 3005180920-2018-01001
• Device Sequence Number: 1901202
• Product Code: JDI
• UDI-Device Identifier: 07630030802621
• UDI-Public: 07630030802621
• 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: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 09/30/2018
• Device Catalogue Number: 01.12.22SN
• Device Lot Number: 134351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/14/2018
• 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: 71 YR