MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136553000

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Cyst(s) (1800); Inflammation (1932); Necrosis (1971); Pain (1994); Synovitis (2094); Tissue Damage (2104); Joint Disorder (2373); Joint Dislocation (2374)

Event Date 11/02/2011

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

Revision due to infection.

Manufacturer Narrative

Product complaint : (b)(4).

Event Description

After review of medical records, laboratory result received for biopsy, it was stated that the material that was sent corresponds to synovial tissue and peripheral fibro-adipose muscular tissue.The synovium shows xanthogranulomatous inflammatory changes, with foamy macrophages, part of them loaded with metallosis, that is to say, fine blackish granules.There is no evidence of acute leukocyte inflammation at any point.There are multiple foci of fibrinoid necrosis.

Manufacturer Narrative

(b)(4).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, will be filed as appropriate.

Event Description

Claim letter alleged metallosis, synovitis, and luxation.The patient was implanted a hip prosthesis (pinnacle cup and metal insert, and furlong hac stem) on (b)(6) 2006, following a diagnose of right coxartrosis with bad articular function.Patient was discharged on (b)(6) with no complications.Patient carried out a perfectly normal life after surgery, including moderate activities.There were actually no relevant symptoms until (b)(6) 2010 when she started feeling pain on the right hip.The medical report mentions that x-rays (not provided) show no alterations regarding the prosthesis, although there is a reference in the medical records to a marked osteopenia at the femur level.There is also reference to a cyst formation.It was considered that these symptoms derived in an incapacity of the claimant and it was decided to carry out the revision surgery.

• Brand Name: ARTICULEZE M HEAD 36MM +8.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8091602
• MDR Text Key: 127953340
• Report Number: 1818910-2018-76100
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033950
• UDI-Public: 10603295033950
• 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,Followup,Followup
• Report Date: 10/26/2018

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: 06/30/2011
• Device Catalogue Number: 136553000
• Device Lot Number: 2186215
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 11/14/2018; 12/10/2018; 12/14/2018
• Supplement Dates FDA Received: 11/28/2018; 12/13/2018; 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR