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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumonia (2011); Joint Dislocation (2374); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 01/09/2008

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.Investigation summary.No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).

Event Description

"literature article entitled, ¿two-stage revision of infected hip arthroplasty using a shortened post-operative course of antibiotics¿ by paul b.Mckenna, et al, published by orthopaedic trauma surgery (2009), vol.129, pp.489-494, was reviewed.The authors present a series 31 infected total hip arthroplasties treated with a two-stage revision and a shortened course of antibiotic therapy was used.The index tha component were unknown.All patients underwent a two-stage revision with a competitor antibiotic cement spacer and competitor antibiotic cement in addition to iv antibiotic therapy before being revised in the second stage.Implanted depuy products: 30 solution stems and 1 charnley stem cemented with competitor cement were paired with depuy femoral heads.The cups, liners, and fixation devices used were competitor products and not included in this complaint.Results: this complaint captures the results associated with the femoral stem and heads used in the study.The results attributed to competitor products are excluded from this complaint.5 cases of dislocation of the revision prostheses- 4 were treated with closed reduction and one was treated with a girdlestone procedure.1 radiographically identified non-union of a femoral fracture-no treatment required.2 patients required postoperative blood transfusions greater than 6 units due to excessive blood loss.2 postoperative periprosthetic fractures- treatment unspecified.2 reinfections treated with iv antibiotics.5 chronic purulent sinus- treated with iv antibiotics.Coded wound infection.1 case of postoperative pneumonia.Captured in this complaint: femoral stem: no reported product problem.Femoral head: implant dislocation.Patient harms: pneumonia, surgical intervention, infection, medical device removal, wound infection, fracture, major bleed, joint dislocation, bone injury.".

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9400975
• MDR Text Key: 185071049
• Report Number: 1818910-2019-119463
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention