SLIDING CORE, UHMPWE,7MM
Report
- Report Number
- 0008031020-2017-00009
- Event Type
- Injury
- Date Received
- January 6, 2017
- Date of Event
- October 26, 2016
- Report Date
- April 21, 2017
- Manufacturer
- STRYKER GMBH
- Product Code
- NTG
- PMA / PMN Number
- P050050
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(6). STRYKER CORPORATION PURCHASED THIS PRODUCT LINE ON (B)(6) 2015 AND WILL TAKE THE RESPONSIBILITY FOR MEDICAL DEVICE REPORTING. DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.
REFERRING TO THE PRODUCT INQUIRY ALL REPORTED ITEMS ARE CONSIDERED PRIMARY PRODUCTS. THE PRODUCTS WERE NOT AVAILABLE TO STRYKER SINCE THEY REMAINED IMPLANTED. HOWEVER, NO PRODUCT MALFUNCTION WAS REPORTED. REVIEW OF THE DEVICE HISTORY RECORDS (INCLUDING RAW MATERIAL AND STERILIZATION CERTIFICATE) OF THE REPORTED IMPLANTS REVEALED NO CONSPICUITIES. THE ITEMS WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. SINCE THE MANUFACTURING DOCUMENTS OF THE REPORTED IMPLANTS SHOWED NO DEVIATION AND BASED ON THE INFORMATION RECEIVED (¿¿A WOUND INFECTION BROUGHT ON BY AN ALLERGIC REACTION FROM THE TOPICAL ANTIBIOTIC OINTMENT OR THE VASELINE GAUZE (REPORTED BY (B)(6)). I/D ON (B)(6) 2016 REVEALED PSEUDOMONAS AERUGINOSA¿¿ AND ACCORDING TO THE COMMENTS OF THE CONSULTING HEALTH CARE PROFESSIONAL ¿THE IMPLANT CAN BE EXCLUDED AS HAVING ANY RELATIONSHIP WITH THE INFECTION; THIS WAS A SUPERFICIAL SKIN INFECTION¿, THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICES. THUS, A REVIEW OF THE EVENT IN LINE WITH ¿(B)(4) HANDLING OF INFECTION COMPLAINTS¿ INCLUDING ¿(B)(4) INFECTION COMPLAINTS - CHECKLIST INVESTIGATOR¿ WAS DEEMED NOT NECESSARY. A REVIEW OF THE COMPLAINT HISTORY, CAPA DATABASES AND RISK FILE DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCTS. NO NON-CONFORMITY WAS IDENTIFIED.
SUBJECT RECEIVED A STAR IN THE LEFT ANKLE ON (B)(6) 2016. SUBJECT PRESENTED WITH ERYTHEMA AROUND THE STAR INCISION SITE ON (B)(6) 2016 AND WAS PRESCRIBED ANTIBIOTICS AND INSTRUCTED TO WATCH THE AREA. SUBJECT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 WITH A WOUND INFECTION BROUGHT ON BY AN ALLERGIC REACTION FROM THE TOPICAL ANTIBIOTIC OINTMENT OR THE VASELINE GAUZE (REPORTED BY (B)(6)). I/D ON (B)(6) 2016 REVEALED PSEUDOMONAS AERUGINOSA. THE SUBJECT WAS TREATED IN THE HOSPITAL WITH IV ANTIBIOTIC AND DISCHARGED ON (B)(6) 2016. SUBJECT WAS INSTRUCTED TO TAKE ANTIBIOTIC BY PICC LINE AT HOME AND TO RETURN TO THE OFFICE FOR FOLLOW-UP ON (B)(6) 2016.
SUBJECT RECEIVED A STAR IN THE LEFT ANKLE ON (B)(6) 2016. SUBJECT PRESENTED WITH ERYTHEMA AROUND THE STAR INCISION SITE ON (B)(6) 2016 AND WAS PRESCRIBED ANTIBIOTICS AND INSTRUCTED TO WATCH THE AREA. SUBJECT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 WITH A WOUND INFECTION BROUGHT ON BY AN ALLERGIC REACTION FROM THE TOPICAL ANTIBIOTIC OINTMENT OR THE VASELINE GAUZE (REPORTED BY (B)(6)). I/D ON (B)(6) 2016 REVEALED PSEUDOMONAS AERUGINOSA. THE SUBJECT WAS TREATED IN THE HOSPITAL WITH IV ANTIBIOTIC AND DISCHARGED ON (B)(6) 2016. SUBJECT WAS INSTRUCTED TO TAKE ANTIBIOTIC BY PICC LINE AT HOME AND TO RETURN TO THE OFFICE FOR FOLLOW-UP ON (B)(6) 2016.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14489 | SLIDING CORE, UHMPWE,7MM | PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME | NTG | STRYKER GMBH | 1433055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |