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 Hypersensitivity/Allergic reaction (1907); Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 06/18/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(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

"literature article entitled, ¿high metal ion levels after use of the asr device correlate with development of pseudotumors and t cell activation¿ by nils p.Hailer dr, med, et al, published by clinical orthopaedic related research (2014), vol.472, pp.953-961, was reviewed.This article analyzes the authors following hypotheses: (1) patients with pseudotumors have higher blood cobalt and chromium concentrations, (2) elevated cobalt and chromium concentrations correlate with increased activation of defined t cell populations, and (3) apart from metal ion concentrations the potential confounders of patient age, high cup inclination, and small implant size are risk factors for development of pseudotumors.The authors reviewed a total 84 hips: 68 asr resurfacing, 10 asr thas with uncemented unknown stem, 4 competitor systems implanted between 2006-2010.Femoral resurfacing components were cemented with depuy smartset hv cement.Patients were examined using ultrasound and whole blood levels of co and cr.Results of immunologic analyses were investigated separately for patients with and without pseudotumors.Pseudotumors were found in 25 hips (35%) and were more common in women.Cobalt and chromium concentrations were greater in patients with pseudotumors than in those without.Specific levels of co and cr were not given.The ranges given were cr up to 15.2 ppb and co up to 35.7.Results: 17 cups with inclination greater than 50 degrees 25 pseudotumors with median size 10 mm 9 revisions due to pain, symptomatic pseudotumors, unspecified loosening, or femoral neck fracture.2 additional patients scheduled for revision surgery.The patient with or scheduled for revision had decreased hip range of motion and pain associated with the pseudotumor formation.Elevated blood metal ions in patients with pseudotumor and those who had revision surgery.Elevated inflammatory markers in an unspecified number of patients.This included white blood cell increase, which the authors note was not an indication for infection.The authors note that there were no infection or dislocations experienced in this study group.The authors did not examine the products explanted in the 9 revision surgeries.The authors do not give the specific location for component loosening nor do they provide information to specify which hips system is associated with the adverse events.Captured in this complaint: asr resurfacing and asr-xl with uncemented stem.Smartset cement for loosening, interface unknown.".

• 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
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9297723
• MDR Text Key: 182455868
• Report Number: 1818910-2019-111712
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention