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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374); Osteolysis (2377); No Code Available (3191)

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, ¿influence of the crowe rating on the outcome of total hip arthroplasty in congenital hip dysplasia¿ by h.U.Cameron, mb, chb, frcsc, et al, published by the journal of arthroplasty (1996), vol.11, no.5, pp.582-587, was reviewed for mdr reportability.In this study, the authors determine the outcome of tha using the s-rom total hip system (depuy) in the various crowe grades of cdh in terms of harris rating, limp, and complications.There were 71 patients with cdh operated on using the s-rom total hip; the control group was composed of 22 patients without cdh operated on using the same implant during the same period as the cdh patients.34 of these were crowe 1, 12 were crowe 2, 8 were crowe 3, and 17 were crowe 4.Results: 17 patients with a moderate limp, 5 patients with a severe limp, 12 radiologically identified osteolysis, 2 delayed femoral nerve palsy, 1 infection- revised twice then converted to a girdlestone, 2 sciatic nerve palsies, 1 dislocation- treatment unknown, i distal periprosthetic femur fracture attributed to patient¿s congenital arthrogryposis.Revised to a long stem 1 napkin ring collapse (osteotomy procedure used to shorten the femur).Revised to a long stem.Captured in this complaint: s-rom cup, liner, and head revised for infection.S-rom liner and head for dislocation.2 s-rom stems and 1 s-rom sleeve revised due to patient comorbidities.Patient harms: osteolysis of cup, head, and liner.Nerve injury, bone injury, joint dislocation, limb asymmetry, infection, surgical intervention and medical device removal.The periprosthetic fracture occurred at the distal tip of the stem and was not attributed to the s-rom sleeve.The twice revised cup, head, and liner are captured in this complaint.".

Manufacturer Narrative

Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: 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 number 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.Per internal procedures, the event information was 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 device history record (dhr) review, was not possible because the required 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.Investigational inputs were requested as indicated per internal procedures for this failure mode.Visual examination of the provided x-ray images found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.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.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9222114
• MDR Text Key: 176511497
• Report Number: 1818910-2019-108628
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention