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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Thrombosis (2100); Joint Dislocation (2374); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 08/31/2014

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, ¿revision of metal-on-metal hip prostheses results in marked reduction of blood cobalt and chromium ion concentrations¿ by olli lainiala bm, et al, published by clinical orthopaedic related research (2015) vol.473, pp.2305-2313, was reviewed.The authors evaluated recalled asr resurfacing and asr tha mom implants who underwent revisions due to armd for indications of component loosening, elevated blood metal ions, and hip function.The mode used in the study included mri, oxford hip score questionnaire, physical examination, and blood metal ions.Inclusion for the study included index surgery with asr implants, revision due to armd after asr recall, and a minimum of 1 year postoperative follow-up with documentation.Blood metal ions are considered elevated if over the 7 ppb threshold.Revision for armd was considered if the patient had one or more of the following: pseudotumor, elevated co and/or cr blood ions and hip symptoms, the patient had progressive hip symptomology regardless of elevated blood metal ions.Failure was classified as being attributed to armd is the following criteria were met: presence of macroscopic synovitis or metallosis, a pseudotumor found during revision surgery, a moderate to high number of perivascular lymphocytes with tissue necrosis, and/or fibrin deposition in the histopathologic sample.Implanted products: 263 revisions.65 asr resurfacing and 198 asr tha.Stems used: 119 summit, 36 corail, 9 s-rom, 1 prodigy, 1 proxima.There were 4 re-revisions due to dislocation, deep infection, and acetabular fracture post op.Results: there were 263 total revisions for armd.227 revisions were only for armd.There were 36 hip revisions that included additional symptomology as well as armd.For the asr tha these included 14 for cup loosening, 12 for infection, 4 for high inclination of cup with mechanical symptoms, 1 for stem loosening, 1 entrapped sciatic nerve, and 1 for impingement.For the asr hra these included 1 for osteolysis of femoral neck, 1 fracture of the femoral neck post operatively, and one loosening of femoral component.Intraoperative findings and complications post-op: aval in 161 hips, 88 cases of osteolysis, 131 pseudotumors, 1 dvt, 2 dislocations.Implanted components at revision: 2 summit stems, 4 s-rom, 3 corail, 4 competitor stems.68 coc delta motion, 55 pinnacle (39 coc, 9 cop, 7 mop), and 96 competitor articulating surfaces.There was an unknown titanium sleeve used with some of the coc systems.An unknown number of stems were cemented with unknown cement discretion.Revision results: these results were not differentiated between competitor.66 patient had elevated blood metal ions greater than 7 ppb.8 patients had ultra-high blood metal ions (cr 40.6-125.Ppb).Some patients reported moderate to severe pain.7 instances of osteolysis identified on radiographic follow-up.This finding is attributed to the asr index implants because these osteolytic lesions were initially discovered at revision.The continuing elevated blood metal ions can also be attributed to the initial asr implants.However, there is not enough information in this article to definitively attribute the remaining elevated ions to the index implants.This complaint will capture the elevated ions to the revised implants.There is not enough information to determine which revised implants were associated with pain and elevated ions.This complaint will capture the revised implants as 1 unknown cup, head, liner, sleeve, and stem.None of these components was re-revised.Captured in this complaint: asr and asr-xl and unk stem at revision 1, asr system, augment, and stem for re-revision (4), and 1 total system for re-revision.A total of 1 index procedure and 2 revisions.".

• 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: 9296639
• MDR Text Key: 183372241
• Report Number: 1818910-2019-111649
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 10/14/2019

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: 10/14/2019
• 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