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

Catalog Number	01.12.022
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 may 2018; lot 072776: (b)(4) items manufactured and released on 05 december 2007.Expiration date: 2012-10-31; no anomalies found related to the problem.To date, all 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 (k103352); 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 sold without any similar reported event.Clinical evaluation performed by medical affairs manager: partial hip revision surgery (stem, head and liner) occurred 10 years after primary cementless total hip arthroplasty.Radiographic image provided shows the presence of localized osteolytic lesions around the stem that looks slightly varus.Polyethylene wear is a common long-term finding, described and quantified in literature, when standard polyethylene liners are usedand and it could be a possible cause of this event.
Event or Problem Description
On (b)(6) 2018 we were informed that the surgeon will revise on (b)(6) a patient due to stem loosening and insert suspected wear.

• Brand Name: 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: 7522298
• Report Number: 3005180920-2018-00339
• Device Sequence Number: 1862435
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 10/31/2012
• Device Catalogue Number: 01.12.022
• Device Lot Number: 072776
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/17/2018
• 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: 76 YR