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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Joint Dislocation (2374); Not Applicable (3189); No Code Available (3191)

Event Date 03/21/2017

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, ¿experience of the posterior lip augmentation device in a regional hip arthroplasty unit as a treatment for recurrent dislocation¿ by l.Hoggett, et al, published by journal of orthopaedics (2017), vol.14, pp.512-514, was reviewed.The purpose of this article is to review the authors¿ experience using the posterior lip augmentation device (plad) to treat recurrent dislocations implanted between january 2007 and november 2012 in 55 hips.Implanted depuy products: all patients had a charnley polyethylene cup paired with a charnley monoblock stem.The plad devices were secured with 5 screws.Dislocation occurred in all hips prior to implantation of the plad device.Results after plad insertion: there were 14 patients who required reoperations or revisions.8 reoperations for dislocations.Treatment included closed reduction, plad revision, acetabular revision, and/or conversion to a girdlestone.1 plad revision due to screw breakage.1 tha revision due to aseptic loosening of the stem.3 cases of infection treated with irrigation and debridement and/or tha revision surgery.Radiographic results: there were 26 cases of radiographically identified trochanteric fracture at the osteotomy site prior to plad insertion.Treatment was not specified.The authors do not specify if any of these events were associated with the revision surgeries noted in the article.There were 35 cases of radiographically identified polyethylene wear noted before plad insertion.11 cases were confirmed macroscopically during plad insertion surgery.Impacted products: charnley polyethylene cup: implant dislocation, implant bearing wear.Charnley monoblock stem: implant loosening/interface unknown, implant dislocation, fracture.Plad implant: no reported product problem.Plad screw: implant fracture/metal.Health impact: surgical intervention, device revision, and medical device removal.Symptoms: infection, joint dislocation".

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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: product complaint (b)(4).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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9716378
• MDR Text Key: 188708249
• Report Number: 1818910-2020-04983
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• 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: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention