MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 S-ROM*SLEEVE PRX ZTT, 18F-LRG; HIP FEMORAL STEM/SLEEVE

Catalog Number 550526

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003); Migration (4003)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hematoma (1884); Muscular Rigidity (1968); Pain (1994); Synovitis (2094); Joint Swelling (2356); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671)

Event Date 05/31/2013

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

On 6/8/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported injuries as outlined in complaint, including but not limited to, additional surgery to remove hardware implanted during revision surgery due to fracture, metallosis, continued pain, and trouble ambulating.Medical records reported thigh pain, hip locking with audible noise, stiffness after sitting, weakness, metal particle associated synovitis, and cup verticle.Mri reportedly showed fluid collection that was most likely a fracture hematoma.Radiograph reportedly showed an oblique transverse displaced greater trochanter fracture, cup appeared to be somewhat abducted and anteriorly placed, stem position in varus with thinning of lateral cortex, osteolysis proximally about the femur and stem, srom proximal body does not appear to be grown in with bone medially.Revision surgical report noted the fracture, left hip hematoma and effusion 200ml, metallosis with elevated metal ions, extensive deep seroma cavity secondary to metallosis, early cup loosening and loose stem, severe periprosthetic osteolysis, 2000ml blood loss with 2 units of packed red blood cells given, extensive surgical time of greater than 4 hours, intense metal staining of all soft tissues, blood loss was related to diffuse bleeding throughout procedure from fracture sites and bony surfaces despite appropriate technique, osteoelytic and metal debris, subluxation of hip from articulation, pre-operatively the socket/cup was 70 degrees vertical inclination and 30 degrees anteversion, corrosion at the trunnion, stem in varus with subsidence and impingement of the liner and head with damage to liner.Patient was revised with competitor products including trochanteric claw and cables to repair fracture.Patient had another surgery in (b)(6) 2014 to remove claw and broken cables and repair muscle.Update: 08/12/2016 in conjunction with the product specialist the sleeve will be added.

Manufacturer Narrative

No device associated with this report was received for examination.From a medical perspective, based on the information available, it is not possible to determine if the complaint is product related.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 5877666
• MDR Text Key: 52161758
• Report Number: 1818910-2016-25147
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K934412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2010
• Device Catalogue Number: 550526
• Device Lot Number: 1840779
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 95