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 Pain (1994); Sepsis (2067); Tachycardia (2095); Joint Dislocation (2374); No Code Available (3191)

Event Date 12/14/2015

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.

Event Description

Literature article received entitled "cementless total hip replacements in sickle cell disease." literature article entitled "cementless total hip replacements in sickle cell disease" by christopher m.Jack, et al, published by hip (14 december 2015) vol.26, no.2, pp186-192, doi: 10.5301/hipint.5000317 was reviewed for mdr reportability.This article reviews the perioperative reaction to tha implants of patients who have sickle cell disease (scd).52 primary thas were carried out in 40 patients: $* s-rom femoral stems, 1 aml femoral stem, and 3 solutions femoral stems; 42 duraloc acetabular cups, 9 pinnacle cups, and 1 delta motion cups; 42 forte on forte acetabular liners and femoral head bearings, 10 delta on delta acetabular liners and femoral heads; and 35 total screws- 7 hips with two screws, 9 hips with no screws, and the remaining hips with one screw.The text of the article does not specify which of the following patient harms applies to which product or device.There were five cased of intraoperative femur fracture during reaming that were treated with cerclage.There were two cases of postoperative dislocation.One was treated with closed reduction and the other was treated with revision, where that patient developed postoperative pseudomonas sepsis.One patient experienced a postoperative ventricular tachycardia (vt) arrest.There were two cases of reported leg lengthening postoperatively due to bone sclerosis preventing adequate femur preparation for the stem.The article discusses the need for patients with scd to receive transfusions because of the nature of their disease process.There were no reported cases of the need for transfusions unrelated to scd or as a result of depuy products or devices.At follow-up, there were no cases of osteolysis with any of the cementless implants.There were no reports of device noise, impingement, inadequate osseointegration, nerve damage, or device fracture.Adverse event(s) related to product(s): unknown acetabular liner (2): implant dislocation: hip.Unknown acetabular head (2): implant dislocation: hip.Patient(s) reported harm(s) prior to procedure: surgical intervention, pain, fracture: intra-op (stem (3) only), sepsis, joint dislocation (cup and liner only), sepsis, tachycardia, limb asymmetry (stem only).

Manufacturer Narrative

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.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.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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8908512
• MDR Text Key: 155209778
• Report Number: 1818910-2019-101546
• Device Sequence Number: 1
• Product Code: KWA
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention