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 Fall (1848); Pain (1994); Distress (2329); Joint Dislocation (2374)

Event Date 02/22/2021

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

(b)(4) received from tga in relation to depuy - corail pinnacle left hip replacement, stem, cup and head.Clinical event information: i had a total left hip replacement on [redacted] using corel pinnacle products, for the stem, cup and head, this dislocated on [redacted].I went to hospital where it was put back into place.It dislocated again three (3) weeks later.I went back to hospital and had it put back into place again.I then went to a rehabilitation hospital where i was operated on.The replaced the cup.To the best of my knowledge they removed cup size 22 and put in cup size 24.I am now being treated for post traumatic stress disorder after this event.Laying on the garage floor in so much pain and calling for help, with no one coming was distressing.This was extremely painful.When my hip dislocated, i was on my own in my garage, i laid on the concrete floor for a long time before neighbours found me.I broke my wrist in the fall.Patient outcome/consequences: i am now being treated for post traumatic stress disorder after this event.Laying on the garage floor in so much pain and calling for help, with no one coming was distressing.No further information available as reporter details have not been disclosed (confidential).

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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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
• MDR Report Key: 12639493
• MDR Text Key: 277104880
• Report Number: 1818910-2021-22802
• 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,o
• Type of Report: Initial,Followup
• Report Date: 10/04/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP FEMORAL STEM CORAIL.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP ACETABULAR LINERS.; UNKNOWN HIP FEMORAL HEAD.
• Patient Outcome(s): Congenital Anomaly