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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH TALAR COMP,SINGLE COATED US VERS XX-SMALL, LEFT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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STRYKER GMBH TALAR COMP,SINGLE COATED US VERS XX-SMALL, LEFT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME Back to Search Results
Catalog Number 400251
Device Problem Entrapment of Device (1212)
Patient Problem Pain (1994)
Event Date 01/16/2015
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
Manufacturer Narrative
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.
 
Event Description
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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Brand Name
TALAR COMP,SINGLE COATED US VERS XX-SMALL, LEFT
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH   2545
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5316288
MDR Text Key34069759
Report Number0008031020-2015-00545
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/07/2014
Device Catalogue Number400251
Device Lot Number060498/0388
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient Weight52
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