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); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348); No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The literature article entitled, "outcomes of cement in cement revision, in revision total hip arthroplasty" written by abhijeet kumar, martyn porter, nikhil shah, chakshu gaba, and paul siney published by clinical science published online 12 december 2019 was reviewed.The article's purpose is to evaluate the effectiveness of cement-in-cement revision of the femoral stem while performing a revision tha.Data was compiled from 75 patients between june 2014 and june 2017.Depuy products were identified as "most" original stems removed among "variety of femoral stems." depuy products were also identified among non-depuy products utilized in revision tha.Cement manufacturer is not identified.The article only identifies and reports on the femoral stems.Therefore, this pc captures the original depuy stems with related revision reasons and the revision depuy stems with related adverse events.Figures 3-5 and 7 provide radiographic imaging but does not identify depicted products.The adverse events in caption descriptions are captured in the generalized adverse events appropriately.Original depuy stems: charnley modular stem, c-stem amt.Revision reasons for original depuy and/or non-depuy stems: stem loosening (interface unknown).Peri-prosthetic fracture (femoral).Loss of bone stock.Femoral component stem fracture.Unexplained pain.Revision depuy stems: charnley modular stem, c-stem amt.Adverse events for revision depuy and/or non-depuy stems: infection (treated by antibiotics and/or 2 stage revision).Stem perforation (treated by re-revision).Periprosthetic femoral fracture (treated conservatively and orif).Sciatic nerve palsy (full recovery in 15 months post op; treatment not reported).Intraoperative fracture (treated by cerclage wire).Dislocations (involved components not identified or reported; treated by re-revision).Femoral component stem fracture (treated by re-revision).

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.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: 10130191
• MDR Text Key: 194474007
• Report Number: 1818910-2020-13351
• Device Sequence Number: 1
• Product Code: KWY
• 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: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• 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: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention