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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH UNK STAR TALUS COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
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STRYKER GMBH UNK STAR TALUS COMPONENT; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME Back to Search Results
Catalog Number UNK_SEL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Wound Dehiscence (1154)
Event Date 10/25/2017
Event Type  Injury  
Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains implanted.
 
Event Description
As reported: "subject experienced wound dehiscence on (b)(6) 2017 following receipt of star ankle on right ankle on (b)(6) 2017.Wound washed and subject treated with antibiotics.Subject placed in cam boot.Event resolved on (b)(6) 2017." submitted aer form indicates that x-rays/dicoms/ct-scans are not available.
 
Event Description
As reported: "subject experienced wound dehiscence on (b)(6) 2017 following receipt of star ankle on right ankle on (b)(6) 2017.Wound washed and subject treated with antibiotics.Subject placed in cam boot.Event resolved on (b)(6) 2017." submitted aer form indicates that x-rays/dicoms/ct-scans are not available.
 
Manufacturer Narrative
Evaluation revealed all three reported star implants to be primary products.No further associated products were reported.The reported products were not available to stryker kiel (¿clinical study¿).The product data (catalogue numbers and lot codes) were not provided.Thus, neither a physical examination nor a product history review was possible in this case.However, the reported issue was classified being not device related by a consulting health care professional.The event was filed during the ¿2-year post-approval study to investigate the star ankle under actual conditions of use¿ ((b)(4)) and has been classified as an adverse event (ae) ¿ relationship to the implant: unrelated.It was reported: "subject [(b)(6)-year-old male patient] experienced wound dehiscence on (b)(6) 2017 following receipt of star ankle on right ankle on (b)(6) 2017.Wound washed and subject treated with antibiotics.Subject placed in cam boot.Event resolved on (b)(6) 2017." the reported issue was evaluated by a health care professional to define whether the products did contribute to the event.The hcp defined the case as ae, according to procedure (b)(4)¿clinical investigation - adverse event reporting¿ a ae (adverse event) is non-device related.Therefore, a relationship between the implants and the reported event can be excluded.Referring to the above a review of the event in line with ¿(b)(4) infection complaints checklist investigator¿ was not expedient.Likewise, the completed ¿(b)(4) infection complaints checklist customer¿ was deemed not necessary in this case.Review of the complaint history, risk analysis and capa databases was deemed dispensable since the products were not suspected to have contributed to the reported event.Based on the above observations the event is not linked to a deficiency of a device but is rather considered patient related.No non-conformity was identified.
 
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Brand Name
UNK STAR TALUS COMPONENT
Type of Device
PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH  2545
MDR Report Key7153308
MDR Text Key96003180
Report Number0008031020-2017-00724
Device Sequence Number1
Product Code NTG
Combination Product (y/n)N
PMA/PMN Number
P050050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue NumberUNK_SEL
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight92
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