DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE manufactured by Depuy Orthopaedics, Inc..

Event Text Entries

[178140562] Pt id: (b)(6). This is a report for the patient right tha. Her right total hip arthroplasty was performed in (b)(6) 2010 and the left in (b)(6) 2011, and both were indicated for osteoarthritis of both hips. These hips were both depuy pinnacle ceramic-on-metal hips. The right hip felt good and worked well after the hip replacement, but she says the left hip never felt good. The left hip clicking progressed and she states she was told that this was due to a problem at her iliopsoas tendon. So the left iliopsoas tendon was surgically released, but the hip continued to click despite this procedure. The left hip began subluxating and became progressively painful in (b)(6) 2018. By (b)(6) 2018, she elected to have the left hip revised by a surgeon in (b)(6). She reports that this surgeon found excessive evidence of adverse reaction to metallic debris at this surgery. Around the time of her left hip revision, her metal levels were checked and her blood and urine cobalt levels were found to be significantly elevated. Her right hip still has a pinnacle ceramic-on-metal articulation. Within the past few months, she had increased her physical therapy and has noticed more lateral soreness at the right hip. Her cobalt levels remain elevated. On (b)(6) 2018, her urine cobalt level was 16. 6 mcg/l and urine chromium level was 50. 2 mcg/l. On (b)(6) 2019, her urine cobalt level was 27. 63 mcg/l and blood cobalt level was 4. 6mcg/l. In (b)(6) 2019, she began taking 600mg of n-acetyl cysteine threes times per day for potential cobalt chelation. Since hip replacement, she has also been experiencing ocular migraines, tinnitus and hearing loss, sleep issues, memory problems, mood disorder, and atrial fibrillation. These symptoms are consistent with cobalt toxicity. Neuro q analysis of her fdg pet brain scan study showed focal and general hypertension suggestive of chronic toxic encephalopathy and different from patterns seen for patients experiencing frontotemporal dementias, alzheimer? S disease, or normal aging. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092772
• MDR Report Key: 9671640
• Date Received: 2020-02-04
• Date of Report: 2020-01-31
• Date of Event: 2018-12-26
• Date Added to Maude: 2020-02-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE
• Generic Name: PROSTHESIS, HIP SEMI-CONSTRAINED, METAL/ CERAMIC/ POLYMER, CEMENTED
• Product Code: MAY
• Date Received: 2020-02-04
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC.

Device Sequence Number: 2

• Brand Name: DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE
• Generic Name: PROSTHESIS, HIP SEMI-CONSTRAINED, METAL/ CERAMIC/ POLYMER, CEMENTED
• Product Code: MAY
• Date Received: 2020-02-04
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: DEPUY ORTHOPAEDICS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-04