MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICULEZE M HEAD 36MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number 1365-52-000

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Ossification (1428); Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Medical record received and claim letter received.After review of medical record, patient was revised to address periprosthetic osteolysis, altr and trunnions.Revision notes stated that the scarred thickened capsule was partially excised and further released.Fairly limited amount of benign appearing joint fluid was identified once the capsule was incised.The metal prosthetic head was dismantled revealing obvious black corrosion material from trunnions the trunnion and the inside surface of the head taper.Remaining debris was removed.Metal acetabular liner with numerous, probably approximately 200 mallet blows on the periphery of the acetabular shell.Backside of the liner and inside surface of the acetabular component were not structurally involved but there was a thin black stained fibrinous membrane that had formed behind the liner which was removed.The 2 acetabular screws were explanted.Patient had elevated metal ion and metallosis.Claim letter alleges pain, discomfort and lack of mobility from the affected hip.Laboratory result stated synovitis and heterotopic ossification doi: (b)(6) 2005 - dor: (b)(6) 2019 (right hip).

Manufacturer 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.

• Brand Name: ARTICULEZE M HEAD 36MM +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: 10260524
• MDR Text Key: 204923515
• Report Number: 1818910-2020-15582
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033936
• UDI-Public: 10603295033936
• Combination Product (y/n): N
• PMA/PMN Number: K980513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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: 1365-52-000
• Device Catalogue Number: 136552000
• Device Lot Number: 1875650
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINNACLE BONE SCREW 35 MM; PINNACLE BONE SCREW 35 MM; PINNACLE MTL INS NEUT36IDX62OD; PINNACLE SECTOR II CUP 62MM; SUMMIT POR TAPER SZ7 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR