MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Skin Irritation (2076); Test Result (2695); No Code Available (3191)

Event Date 11/09/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article "two cases of metallosis from metal-on-polyethylene total hips: an emerging problem" by cyrus kao, md, raymond scalettar, md, dsc, macr, facp, and robert d.Bunning, md, facp, facr published by american academy of physical medicine and rehabilitation journal http://dx.Doi.Org/10.1016/j.Pmrj.2014.11.004 on 9 november 2014 was reviewed for mdv reportability.The first case is of a patient with non-depuy products.The second case is a 83 year old male physician who received left tha in 2006 a depuy pinnacle cup and prodigy stem system with articulation of metal-on-polyethylene.In march 2011 ((b)(6) years old), he noted spasms of left thigh and gluteal muscles in standing and relieved by chaking leg with mild hip pain.The article notes: " his past medical history was significant for probable rheumatic fever, left elbow osteochondromatosis, osteoarthritis, mild hypertension, benign prostate hypertrophy, and glaucoma.Surgical history included a left elbow synovectomy, a right total hip replacement in 2005, and a left total hip replacement in 2006.In may 2012, he began developing chest wall acne vulgaris, which responded to minocycline, doxycycline, and tretinoin.In june 2012, he developed left leg erythema nodosum, which responded to ibuprofen.In august 2012, he developed progressive generalized fatigue, general weakness, left leg weakness, and difficulty dressing shortly afterward.By october 2012, he had progressive hip pain requiring percocet (acetaminophen and oxycodone) and ibuprofen.Physical therapy did not help.Differential diagnosis included septic left hip and loosening of his hip implant.An mri of his left hip revealed synovial thickening, mild extracapsular edema which suggested the differentials of early septic arthritis or ¿particle disease.¿ blood work was significant for elevated cobalt, chromium, erythrocyte sedimentation rate, and c-reactive protein.He was mildly anemic and had mild renal disease.Thyroid stimulating hormone was normal.Three months after his left hip revision, his cobalt and chromium levels had significantly decreased to 2.7 mg/l and 2.3 mg/l, respectively.Hemoglobin and creatinine levels normalized." article does not clarify loosening details.Adverse events: skin reactions, elevated blood ion levels, pain, surgical revision, foreign body reaction.Impacted products: pinnacle poly liner, prodigy metal head.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9005886
• MDR Text Key: 161970925
• Report Number: 1818910-2019-103908
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention