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

Catalog Number	01.12.032
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation: hip revision surgery performed 5 years and 5 months after total hip arthroplasty in a young, active man ((b)(6) year old).Radiographic image provided shows the presence of radiolucent lines around the stem and the formation of pedestal.The stem looks slightly undersized.The reason of this choice is unknown: patient anatomy and bone morphology may be one reason but this cannot be confirmed not having preoperative x-rays.Aseptic loosening is a possible, literature described adverse event after cementless total hip arthroplasty and causes are often unknown.The reason of this failure cannot be determined.Batch review performed on 19-07-2019: lot 070675/t: (b)(4) items manufactured and released on 24-jan-2019.Expiration date: 2016-12-31.(b)(4) items manufactured and released on 16-dec-2013.Expiration date: 2018-10-31.In both cases, no anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient returned with pain and radiographic evidence of proximal lucency, distal tip bone ingrowth only.The patient was quite active very early on following the primary surgery and this, along with the tight distal femoral canal (dorr type a) may have contributed to the reason for revision.Surgeon revised the hip, stem and head were removed almost 5 years and 5 months after primary.The surgery was completed successfully.On july 15 we were informed about the revision surgery that was performed on (b)(6).
Additional Manufacturer Narrative
On october 30th 2019 we have received the itme involved in the complaint.Visual inspection performed by r&d project manager: femoral stem shows signs of extraction on the neck region and coating residuals on the proximal frontal, medial and lateral parts.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8883100
• Report Number: 3005180920-2019-00672
• Device Sequence Number: 2397346
• Product Code: JDI
• UDI-Device Identifier: 07630030802140
• UDI-Public: 07630030802140
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 10/31/2018
• Device Catalogue Number: 01.12.032
• Device Lot Number: 070675/T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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
• Patient Age: 54 YR