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 Problem Joint Dislocation (2374)

Event Date 11/06/2013

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, ¿the effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs¿ by jonathan hutt, et al, published by international orthopaedics (2014), vol.38, pp.1131-1137, was reviewed.This study was a prospective randomized trial comparing surface finish and the effect of a collar on cemented femoral component subsidence, survivorship and clinical function in 163 hips implanted between 1997-2003.Implanted depuy products: ultima-xl cemented femoral stems manufactured specifically for the trial, 28-mm ceramic femoral heads, and an ultima polyethylene cemented acetabular cup.The manufacturer of the cement used in this study is unknown.Results: 1 patient with 2 dislocations treated with closed reduction.1 patient experienced a postoperative periprosthetic femoral fracture that was treated with orif.The authors speculated that the fracture was the result of a suspected breach of the femur during intraoperative broaching.There is insufficient information provided to definitively attribute the periprosthetic femoral fracture to the intraoperative femoral broaching.1 postoperative periprosthetic traumatic femoral fracture caused by an auto accident.This fracture is not attributed to the stem.There was an unknown number of radiographically identified stem subsidence- no patient consequences.3 cases of radiographically identified stem loosening- no patient consequences.There is insufficient information provided to attribute the loosening to the stem that was cemented with competitor cement.Captured in this complaint: ultima polyethylene cup: implant dislocation.28-mm ceramic femoral head: implant dislocation.Ultima-xl femoral stem: implant migration: no patient consequences.Ultima-xl femoral stem: no reported product problem, fracture post-op, surgical intervention.".

• 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
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9425522
• MDR Text Key: 185237674
• Report Number: 1818910-2019-121372
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/17/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2019
• Initial Date FDA Received: 12/06/2019
• 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