MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2011

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary, no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(b)(4).

Event Description

"literature article entitled, ¿subsidence of the corail femoral component in the elderly.A retrospective radiological review¿ by mohammad faisal, et al, published by hip international (2011), vol.21, no.3, pp.325-329, was reviewed.The aim of our study was to look at the radiological results of uncemented tha in the elderly, to identify the number of patients who developed subsidence within the first year after surgery, whether this was progressive, whether it was related to bone quality, and whether the stems ultimately became stable.All patients were implanted with corail femoral stems.This complaint captures the 13 patients with identified stem migration.Case 1 is captured in (b)(4).Case 2 through case 13 are captured in the attached guidance document and are linked to (b)(4)." (b)(6) yo female patient showed signs of radiologically identified corail stem migration of 8.50-mm.Stem was stable with bony ingrowth at final follow-up.No intervention required and no patient consequences.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9463583
• MDR Text Key: 217440283
• Report Number: 1818910-2019-122907
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR