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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Nonstandard Device (1420); Naturally Worn (2988)

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

Event Date 06/26/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).¿metal presence in hair after metal-on-metal resurfacing arthroplasty¿ by mari´a rodri´guez de la flor et al.(b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

An article ¿metal presence in hair after metal-on-metal resurfacing arthroplasty¿ by mari´a rodri´guez de la flor et al reports on establishing whether the hair of patients with metal-on-metal prostheses shows an unusually high concentration of metal ions and to determine whether such values change depending on the time since implantation.It also finds out whether the variations of metal presence in serum and urine are consistent with those in hair and to ascertain whether the values of metal levels in hair decrease when removing the metal-on-metal arthroplasty via revision surgery.Depuy asr system (depuy) was implanted in 45 patients (2 women and 43 men, mean age 57± 9 years) between 2005¿2009.The study was performed in an average period of 52 months after the implantation.A total of 756 assessments of blood, urine, and hair samples were performed for this study.2 patients were lost to follow up.Both cr and co levels in serum and urine were much higher than those considered normal.Mean cr and co levels in serum were 8.29 mg/l and 8.38 mg/l, respectively, whereas in urine levels were 16.20 mg/l and 75.40 mg/l respectively.In hair, mean cr level were 163.27 mg/g, mean co level 61.98 mg/g, and mo 31.36 mg/g.A high concordance was observed between chromium-urine and chromium-serum, and between cobalt-urine and cobalt-hair; a moderate concordance was present between cobalt-urine and cobalt-serum, and between cobalt-hair and cobalt-serum.11 cases of revision surgery was performed due to the following reasons: femoral neck fracture (n=2), relapsing luxation (n=1), elevated metal levels and presence of periarticular cyst found by mri (n=5), pain due to uncertain nature (n=3).At 1 year after reintervention, analytics were performed again and the following decrease rates were found: 42.8% in cr levels, 51.1% in mo levels, and 90.3% in co levels.No clarification was found on which events were specifically present on specific patients.Impacted products asr resurfacing implants.

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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Device history lot : null.Device history batch : null.Device history review : null.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 road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 8890909
• MDR Text Key: 154271533
• Report Number: 1818910-2019-101048
• Device Sequence Number: 0
• Product Code: KXA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention