MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL HEAD METAL ELITE; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Sepsis (2067); Joint Dislocation (2374)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

Article entitled ¿does radiopaque cement conceal periprosthetic bone loss around femoral stems" written by bernhard flatoy, jon dahl, stephan maximilian rohrl and lars nordsletten, published by hip international, 22 april 2019, was reviewed.The articles purpose was to determine ¿does radiopaque cement conceal periprosthetic bone loss around femoral stems?¿.All patients in the study received cemented depuy products, including: charnley roundback or flanged stems with tantalum beads attached, cemented ogee cup and elite modular 22.2 or 28mm head.Three different type of competitor cement were used.There were 30 patient¿s initially included, 10 in each group.Reportable events noted included: 2 septic revisions, 1 of which died 5 months later and 1 dislocation with revision.The authors did not specify which depuy product was associated with the results reported in this article.The adverse events will be captured as unknown depuy products.In this trial, it was observed that periprosthetic bone mineral density changes are less pronounced in the presence of radiopaque cement compared to radiolucent cement when measured by dxa (dual-energy x-ray absorptiometry.As periprosthetic fractures account for a significant share of femoral revisions, preliminary trials evaluating bone remodeling is warranted as a part of phased introduction of new femoral implants.The use of radiolucent cement could prove useful in order to improve the accuracy of such screening tools.

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 number 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK HIP FEMORAL HEAD METAL ELITE
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12321254
• MDR Text Key: 266664637
• Report Number: 1818910-2021-17878
• Device Sequence Number: 1
• Product Code: JDI
• 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: 07/23/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention