MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Thrombosis (2100); Heart Failure (2206); Test Result (2695); No Code Available (3191)

Event Date 02/06/2014

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 "missing elements of the history" by larry a.Allen, m.D., amrut v.Ambardekar, m.D., kalpana m.Devaraj, m.D., joseph j.Maleszewski, m.D., and eugene e.Wolfel, m.D.Published by the new england journal of medicine on 6 feburary 2014 was reviewed for reportability.The article reports on a (b)(6) year old woman who has a bilatera asr summit hip implant system.The article reports she "presented to her primary care physician with cough, exertional dyspnea, and foot swelling that had developed 2 weeks earlier while she was vacationing in (b)(6).She had no rhinorrhea, pharyngitis, fever, rash, diarrhea, or new joint symptoms.Her medical history was notable for polyarthritis, for which her rheumatologist prescribed minocycline and meloxicam.She had undergone right total hip replacement 4 years previously, left total hip replacement 3 years previously, and left total knee replacement 1 year previously.There was no history of hypertension or diabetes.She had never used tobacco, illicit drugs, or herbal supplements and did not consume large amounts of alcohol.She was married and primarily had been a homemaker for her three children, and she did not have known occupational exposures.There was no family history of early-onset pulmonary or cardiovascular disease.Vital signs were within normal limits.She received a diagnosis of pneumonia and ¿travel-related edema¿ and was treated with a course of antibiotics; no chest imaging or blood tests were performed, and she did not receive diuretics." over time she presented with dyspnea, edema, fatigue, that bilateral lower-leg edema that progressed to the point where she required left ventricular assist device leading to a heart transplant 5 months later.13 months prior to heart transplant she was informed of the asr recall and was recommended to plain radiography and clinical examination every 6 months which revealed no evidence of abnormality of the prosthesis."however, 7 months after transplantation, the patient was advised to undergo further hip imaging and measurement of serum cobalt levels owing to further safety concerns with her hip prostheses.Pelvic mri showed bilateral thin-walled fluid collections that were consistent with pseudotumors caused by a reaction to metal implants (¿metallosis¿) (fig.3); the serum cobalt level was 287.6 g per liter (reference value, <1.0)." arrangements were made with the heart transplantation team for the patient to receive replacements of the asr products performing left hip first and then right hip 9 weeks later.Revision surgery confirmed the metallosis with findings of gross metal staining along the entire anterior aspect of the abductor system, a pseudotumor on the iliotibial band and metallosis present on the hip joint.The article reports: "the postoperative course was complicated by deconditioning, a fall, and deep-vein thrombosis.After removal of both metal-on-metal hips, the serum cobalt levels rapidly decreased, the serum bnp level decreased, and the lvef returned to the normal range (table 1).With rehabilitation, the patient reported, ¿i feel stronger daily.¿.

Manufacturer Narrative

Updated info.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8961344
• MDR Text Key: 160930541
• Report Number: 1818910-2019-102833
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• 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
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention