MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-51-000

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Date 10/02/2020

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.

Event Description

Patient underwent a thr on the (b)(6) 2020 - suffered subsequent post operative dislocations.Upon further investigation it as discovered that the incorrect femoral head was implanted that did not match the pinnacle liner that was implanted.Both head and liner were removed and exchanged.This error was not picked up at the time of original surgery despite the implants being visually checked by three separate people in the theatre prior to opening and subsequent implantation, nor did the surgeon recognize the error post final reduction during the primary surgery.The writing on the boxes can sometimes be blurred/obstructed by glare from the lights and seams from the dust proof wrapping around the implants prior to opening.Speed and lack of attention may also have been a factor, but the exact cause is unclear and all parties involved in the primary surgery have discussed the issue and agreed to take more care when confirming implant selection prior to opening.Affected side: right.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of a singular x-ray image does depict and confirm the reported dislocation event.It was not possible however to determine the root cause.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10690713
• MDR Text Key: 211708590
• Report Number: 1818910-2020-22601
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: 10603295033912
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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 Model Number: 1365-51-000
• Device Catalogue Number: 136551000
• Device Lot Number: 9437830
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINN MAR NEUT 32IDX52OD; PINN MAR NEUT 32IDX52OD
• Patient Outcome(s): Required Intervention