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); Joint Dislocation (2374); No Code Available (3191)

Event Date 11/11/2011

Event Type  Injury  

Manufacturer Narrative

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.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.(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 entitled, ¿subsidence of collarless uncemented femoral stems in total hips replacements performed for trauma¿ by alanna k.Pentlow and james s.Heal, published by injury: international journal for the care of the injured (2012), vol.43, pp.882-885, was reviewed.The aim of this study was to assess whether early subsidence occurred when collarless uncemented stems were used to treat trauma patients implanted between december 2007 - december 2009.Implanted depuy products: all 82 patients were implanted with a pinnacle cup, an unknown depuy acetabular liner and femoral head, and a corail stem.46 patients were implanted due to femoral neck fracture sustained by unspecified trauma and 36 patients were implanted with the tha as an elective procedure.Results: 1 revision of the stem 3 days postoperatively due to dislocation secondary to subsidence of the femoral stem.1 revision of the stem 9 days postoperatively due to dislocation secondary to subsidence of the femoral stem.1 total revision 25 days postoperatively due to infection.1 dislocation treated with closed reduction.80 instances of non-progressive stem subsidence identified on dexa scans.There was no treatment required and all stems were stable at final follow-up.Captured in this complaint: 2 corail stems: implant migration.1 pinnacle cup: no reported product problem.3 acetabular liners: implant dislocation.3 femoral head: implant dislocation.Patient harms: infection, surgical intervention, medical device removal, joint dislocation.80 corail stems: implant migration, no patient consequences.".

• 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: 9418634
• MDR Text Key: 185082199
• Report Number: 1818910-2019-119242
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 11/13/2019
• 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