MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for UNKNOWN HIP FEMORAL HEAD UNK HIP FEMORAL HEAD manufactured by Depuy Orthopaedics Inc Us.
[188632645]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188632646]
This is a report for the patient right tha. Her right total hip arthroplasty was performed in 2010 and left in 2011. 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 become progressively painful in 2018. By 2018 she elected to have the left hip revised by a surgeon. 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 notices more lateral soreness at the right hip. Her cobalt levels remain elevated on 2018. Her urine cobalt level was 16. 6 mcg/l and urine chromium level was 50. 2 mcg/l on 2019. Her urine cobalt level was 27. 63 mcg/l and blood cobalt level was 4. 6 mcg/l in 2019. She began taking 600 mg of n-acetyl cysteine three times per day for potential cobalt chelation since hip replacement. She has 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 should focal and general hypertension suggestive of chronic toxic encephalopathy and different from patterns seen for patients experiencing fronto temporal dementias, alzheimers disease or normal aging. Doi: (b)(6) 2011, dor: (b)(6) 2018, left hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-07569 |
| MDR Report Key | 9823642 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-24 |
| Date of Event | 2018-09-01 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN HIP FEMORAL HEAD |
| Generic Name | HIP FEMORAL HEAD |
| Product Code | KXA |
| Date Received | 2020-03-12 |
| Catalog Number | UNK HIP FEMORAL HEAD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |