MAUDE Adverse Event Report: STRYKER GMBH SLIDING CORE, UHMPWE,7MM; PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED, METAL/POLYME

Catalog Number 400141F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Post Operative Wound Infection (2446)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SLIDING CORE, UHMPWE,7MM
• 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: 6231106
• MDR Text Key: 64130575
• Report Number: 0008031020-2017-00009
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 400141F
• Device Lot Number: 1433055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Weight: 98