MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4; CEMENTLESS HIP STEM

Catalog Number	01.12.034
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/16/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 april 2018.Lot 081305: (b)(4) items manufactured and released on 10 july 2008.Expiration date: 2013-05-31.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported event.Clinical evaluatiuon performed on 19 april 2018 by medical affairs: partial hip revision surgery (stem and head) occurred 8 years after primary cementless total hip arthroplasty in a (b)(6) year old man.The patients was complaining about pain and the surgeon determined that the stem loosened.Aseptic loosening is a possible literature described mid/long term adverse event after primary cementless tha and causes are often unknown.In such a case, the suspicion of an infecting agent comes round, because the appearance of femur does not lead to suspect a mechanical failure which should be visible given the time frame.However, no elements support this hypothesis.Therefore, the reason of this event cannot be determined.
Event or Problem Description
Revision due to pain on the femur about 8 years after primary.The stem was loose.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7442814
• Report Number: 3005180920-2018-00244
• Device Sequence Number: 1718361
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• 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: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: Home Health Aide
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 01.12.034
• Device Lot Number: 081305
• 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: 03/20/2018
• Initial Report FDA Received Date: 04/19/2018
• 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: 61 YR
• Patient Weight: 88