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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/13/2014

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

Literature article entitled, ¿midterm outcomes of the recently fda approved ceramic on ceramic bearing in total hip arthroplasty patients under 65 years of age¿ by ahmed a.Aoude, md, et al, published by the journal of arthroplasty (2015), vol.30, pp.1388-1392, was reviewed.The present study aimed to evaluate the mid-term results of the fourth generation of ceramic on ceramic (cc) bearing.Demographics, surgical technique, complications, clinical and radiologic outcomes were analyzed in a series of 133 consecutive cc total hip arthroplasties (thas) with a newest generation cc bearing to determine if these provide safe and well performing bearings.This is a follow-up study of outcomes previously reported in pc-000562128.This complaint will capture those results that have not been previously reported.Implanted depuy products: pinnacle cup, ceramic liner and head, and s-rom or trilock femoral stem.Results: 1 patient with pain, decreased joint range of motion.Recommended for revision surgery due to aseptic loosening of the stem secondary to inadequate osseointegration.The patient has refused revision surgery and is under close observation.1 patient under observation for a radiographically loose stem.Revision surgery has not been recommended because the loosening is asymptomatic.The authors identify an additional patient, labeled (b)(6) male, captured in the guidance document.Captured in parent pc-000590809: one femoral stem and one s-rom femoral augment: implant loosening.Patient harms: pain, medical device site joint range of motion decreased, inadequate osseointegration.

Manufacturer Narrative

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 number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.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 number was not provided.Visual examination of the provided x-ray images on (b)(4) found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.The reported event is considered one of the possible complications of joint replacement.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 at the time it was released for distribution.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 indicated.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: 9385270
• MDR Text Key: 184330110
• Report Number: 1818910-2019-118494
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention