MAUDE Adverse Event Report: STRYKER GMBH SLIDJNG CORE, UHMPWE,8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400142F

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Scarring (2061); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/22/2015

Event Type  Injury  

Event Description

It was reported that the surgeon was doing surgery on the patient again for a non related issue but would like to clean out the medial/lateral gutters some more as well as replace the poly.Reason for revision surgery is ankle joint stiffness.Bone quality is good.Surgical site had formation of scar tissue in the ankle joint and all around poly and metal components.No complications reported.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

Evaluation revealed the sliding core uhmpwe, 7mm to be the subject product.No further associated products were reported.Deficiency in material or manufacturing was not found.The affected sliding core was documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.In the case presented a female patient had been treated with a scandinavian total ankle replacement on (b)(6) 2013 due to a right ankle degenerative joint disease.On (b)(6) 2015 the patient was revised since she had ¿decreased mobility¿ and pain due to ¿scar tissue and bony exostosis formation¿.The received sliding core showed minor traces of use.Signs of damage, significant wear or a breakage could not be found.Furthermore radiographs and ct scans taken during the follow-up examinations showed an ¿overall osseous alignment of the implant.The components are intact and show no evidence of loosening; with no lysis noted.Based on the above information the revision surgery was indicated as the patient had an ankle joint stiffness and pain caused by bony ingrowth (bony exostosis formation) and by scar tissue.The implants and their positions looked good.The sliding core was routinely changed and was not worn.The tibial- and the talar component were not explanted.It can be assumed that the implants worked like specified.A manufacturer related issue could be excluded.Bony ingrowth and bone impingement in general had been experienced and are nominated in the scientific literature as known complications: ¿development of postoperative periarticular ossification can lead to pain and stiffness after total ankle replacement.Gutter pain can develop in 25% of patients.Debridement of soft tissue and bony impingement may be required.Little is known about relative risk of impingement based on implant design and degree of medial and lateral talar facet coverage.Attention should be given intraoperatively to be sure arthritic osteophytes are not impinging after implant placement.¿ bony ingrowth had been furthermore clinically assessed by a hcp: ¿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.¿ bone ingrowth is an adverse effect and may require medical or surgical intervention (therefore is listed in the ifu).

Event Description

It was reported that the surgeon was doing surgery on the patient again for a non related issue but would like to clean out the medial/lateral gutters some more as well as replace the poly.Reason for revision surgery is ankle joint stiffness.Bone quality is good.Surgical site had formation of scar tissue in the ankle joint and all around poly and metal components.No complications reported.

• Brand Name: SLIDJNG CORE, UHMPWE,8MM
• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4926476
• MDR Text Key: 6032255
• Report Number: 0008031020-2015-00316
• Device Sequence Number: 1
• Product Code: NTG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 400142F
• Device Lot Number: 1010032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR