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

Model Number 1365-54-000

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

Psf and medical records received.After review of medical records patient was revised to addressed failed right metal on metal total hip arthroplasty with pseudotumor and osteolysis of proximal femur.Operative notes indicated pain, discomfort, walking difficulty, clicking, elevated metal ion levels, metallosis, swelling and significant metal debris as well within the greater trochanter had a fairly large area in that juncture.Doi: on or around (b)(6) 2002 - dor: (b)(6) 2017 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The provided photographs depict the revised metal liner and femoral head.No conclusions can be drawn as to a root cause for the reported allegations using these photographs.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 +12
• 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: 10706555
• MDR Text Key: 212146041
• Report Number: 1818910-2020-22893
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033974
• UDI-Public: 10603295033974
• 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: 10/06/2020

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: 1365-54-000
• Device Catalogue Number: 136554000
• Device Lot Number: YLN-49
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APEX HOLE ELIM POSITIVE STOP; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM; SUMMIT POR TAPER SZ8 HI OFF; APEX HOLE ELIM POSITIVE STOP; PINNACLE MTL INS NEUT36IDX56OD; PINNACLE SECTOR II CUP 56MM; SUMMIT POR TAPER SZ8 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR