STRYKER GMBH TALAR COMP,SINGLE COATED US VERS XX-SMALL, LEFT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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Catalog Number 400251 |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Pain (1994)
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Event Date 01/16/2015 |
Event Type
Injury
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Manufacturer Narrative
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The reported device was manufactured and distributed by (b)(4) and implanted prior to howmedica osteonics corp.¿s purchase of certain assets of (b)(4) on august 1, 2014.Stryker became legal manufacturer of this product on april 1, 2015 and has taken the responsibility for medical device reporting.Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Unknown talar component: extra extra small (28mm x 29mm), left.Device will not be returned.
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Event Description
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Star implant was replaced due to pain, impingement, and arthrofibrosis at the non-study institution (hospital for special surgery).Patient has pain and stiffness in the ankle and is not very active.There was significant bony overgrowth on both the medial and lateral gutters.Debridement was done to both gutters and the polyethylene insert was removed.After debridement was completed, a new 10mm polyethylene insert was placed.There was significant scar formation at the anterior aspect of the ankle, and bony overgrowth on the tibial component.Posteriorly, there was significant scarring along the posterior capsule with some early bone formation heterotopic ossification.
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Manufacturer Narrative
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All implants were classified as primary products during investigation.No deviations were found during review of the manufacturing and inspection documents (dhr).The implants were documented as faultless prior to distribution.According to the study records and surgery notes bone growth on medial and lateral gutters plus arthrofibrosis (hypertrophic bone formation) were noted after approx.2.5 years of implantation.The sliding core was exchanged to a new one.After further approx.10 months radiolucencies (cyst) were detected at the lateral edge of the tibia tray.Bone ingrowth and cysts were evaluated by a hcp in the statement ¿clinical results of the star ankle prosthesis, page 69 - 72¿: ¿cyst formation (bone resorption) (0 ¿ 16 %) [1, 6, 9, 10, 12, 13, 15, 17, 20, 24, 27, 28, 30] spontaneous bone resorption and cyst formation represents a significant problem in ankle arthroplasty.The symptoms may be mild and will not require specific surgical measures, but in many cases revision surgery with bone grafting may be required.In advanced cases cyst formation may cause a collapse of the arthroplasty requiring implant removal and ankle fusion.[¿] heterotopic ossification (symptomatic: 0 ¿ 15 %) [2, 6, 9, 23, 27], (asymptomatic 0 ¿ 47 %) [6, 9, 23, 27] the definition of heterotopic ossification is inconsistent in the scientific literature.In most cases it is an incidental finding on the x-rays with no symptoms.Only in rare cases symptomatic heterotopic ossification is found impeding the function of the arthroplasty or causing pain.Symptomatic heterotopic ossification may be treated resection and release.All reported potential risks and complications nominated above represent typical complications of ankle arthroplasty and are not related to the particular design of star.[¿] all reported potential risks and complications nominated above represent typical complications of ankle arthroplasty and are not related to the particular design of star.¿ additionally cysts were evaluated by a product expert from the development department: ¿this is a known complication and risk in the scientific literature.The exact source is unknown.Researchers believe that it is due to poly wear debris and/or fluid hydraulic pressure in the joint.¿ bone ingrowth and cysts are adverse effects and may require medical or surgical intervention (therefore listed in the ifu).Conclusion: based on the evaluation a manufacturing fault was not found but a correlation between the implant and the cysts and bone growth cannot be excluded.Discrepancies were detected during risk analysis review; nc#937715 was already initiated.No other non-conformity identified; no previous or actual actions are in place.
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Event Description
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Star implant was replaced due to pain, impingement, and arthrofibrosis at the non-study institution (hospital for special surgery).Patient has pain and stiffness in the ankle and is not very active.There was significant bony overgrowth on both the medial and lateral gutters.Debridement was done to both gutters and the polyethylene insert was removed.After debridement was completed, a new 10mm polyethylene insert was placed.There was significant scar formation at the anterior aspect of the ankle, and bony overgrowth on the tibial component.Posteriorly, there was significant scarring along the posterior capsule with some early bone formation heterotopic ossification.
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