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

Catalog Number	01.12.032
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2018.Lot 081458: (b)(4) items manufactured and released on 10 july 2008.Expiration date: 2013-05-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other device involved: liner: cc e cc light flat pe liner ø 28 / e reference 01.26.2844stt.Lot 060220: (b)(4) items manufactured and released on 18 april 2006.Expiration date: 2011-02-28.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 medica affaris manager: hip revision surgery occurred 9 years after primary cementless total hip arthroplasty.Radiographic images provided show the presence of radiolucent lines around the stem and signs of stress shielding.Aseptic loosening is a possible, literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this event cannot be determined.
Event or Problem Description
On (b)(6) 2018 we were informed that a revision surgery will be performed due to aseptic femoral loosening, the reason is probably pe wear.
Additional Manufacturer Narrative
On 30 october 2018 we were informed that the suspected pe wear is not confirmed.The event description is revision surgery performed, 9 years after primary surgery, due to aseptic femoral loosening.

• Brand Name: 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 8019251
• Report Number: 3005180920-2018-00850
• Device Sequence Number: 1578727
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

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: 05/31/2013
• Device Catalogue Number: 01.12.032
• Device Lot Number: 081458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 10/31/2018
• 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