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

Catalog Number 550524

Device Problems Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Joint Swelling (2356); Osteolysis (2377)

Event Date 12/18/2013

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

Pfs and medical records received.After review of the medical records for mdr reportability, the patient was revised on (b)(6) 2013 for infection, pain, and septic loosening of the femoral implant.All implants were revised and spacers were placed.At this time no infection is alleged per litigation.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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

Depuy still considers this investigation closed at this time.

Event Description

Update 1/11/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Medical records reported right hip drainage, redness, inflammation, warmth, right thigh swelling, and induration with a hematoma evacuated and wound vac placed.Medical records also reported patient developed massive bleed into thigh with cellulitis and early infection of hematoma.Patient had severe pain, limited range of motion, mri that showed deep infection and was positive for staph coagulase.There was osteolysis, inflammatory response and a fluid collection with sinus tract on mri.Revision surgical report noted a large 20cm defect exposing underlying bone and sinus tract that was debrided.There was no documentation of femoral implant loosening.All components were removed and antibiotic spacers placed.The complaint was updated on: feb 1, 2016.

• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5245436
• MDR Text Key: 31971084
• Report Number: 1818910-2015-35793
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK934412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2015

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 Expiration Date: 11/02/2006
• Device Catalogue Number: 550524
• Device Lot Number: 1001532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2016; 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 91