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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Nerve Damage (1979); Thrombosis (2100); No Code Available (3191)

Event Date 10/22/2019

Event Type  Injury  

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.(b)(4).

Event Description

The literature article entitled, "long-term results of hip arthroplasty using extensive porous-coated stem¿a minimum follow-up of 15 years" written by myung hoon park, md, yung hun youn, md, joon soon kang, md, phd, and kyoung ho moon, md, phd published by geriatric orthopaedic surgery and rehabilitation accepted by publisher 22 october 2019 was reviewed.The article's purpose is to report the clinical and radiographic results of hip arthroplasty using extensive porous-coated stem at a minimum 15 years in korea.All products were depuy products.Data was compiled from 210 patients (286 hips - 232 were total hip arthroplasties and 36 hips of bipolar hemiarthroplasties) consisting of 148 males and 120 females with age range 52-80 years.The article does not identify the specific product platforms associated with the adverse events.The article does not clarify if stems were cemented or uncemented but notes that acetabular cups were uncemented.Depuy products: aml stems, ceramic heads, cocr heads, poly liners, ceramic liners, duraloc cups, pinnacle cups.Adverse events: figure 1 provides radiographic imaging of a (b)(6) year old male patient that is diagnosed with osteolysis on acetabulum 11 years post op and was treated by cup revision.The article relates osteolysis to poly liner wear.Dislocations (treated by cup revision).Periprosthetic fracture (no further information provided regarding time of occurrence or interventions provided).Sciatic nerve injury (no further information provided regarding impact, outcome or interventions provided).Deep vein thrombosis (no further information provided regarding interventions provided).Infection (treated by cup revision).Stem loosening (treated by cup revision).Acetabulum osteolysis associated with poly liner wear (treated by cup revision).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required part/lot number was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not identified.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot:null.Device history batch: null.Device history review : null.

• 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: 9842405
• MDR Text Key: 191100138
• Report Number: 1818910-2020-08248
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• 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: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention