MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXTRA & EXCEL POLYESTER SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Death (1802); Unspecified Infection (1930); Inflammation (1932); Surgical procedure (2357); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent a knee replacement procedure in 2014 and suture was used.While performing the surgery, the surgeon irrigated the wound and closed it with staples.Subsequent to the surgical procedure, the patient developed infections secondary to the surgery.He had another procedure with irrigation and debridement of the right knee, but the knee prosthesis was not removed.The infections persisted for months and were not adequately controlled, and the patient eventually died.No additional information was provided.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4).It was reported by an attorney that the patient underwent a knee replacement procedure in 2014 and suture was used.It was reported that the patient underwent a bilateral total knee arthroplasty on (b)(6) 2014, and the medial and lateral menisci were removed on left and right knees.The anterior cruciate was removed and the posterior cruciate was removed on left and right knees.The permanent components were cemented into place (same size, both knees).The wounds were thoroughly irrigated and closed using suture subcutaneously, and staples to the skin.A compression dressing was then placed.On (b)(6) 2014, the patient was admitted for wound dehiscence ¿ infection and inflammation.It was reported that the patient underwent i&d with wound vac of the left knee, and the patient was discharged on (b)(6) 2014, with wound care instructions and iv antibiotics.It was reported that the patient had an aspiration under anesthesia of left knee wound on (b)(6) 2014, due to persistent pain.On (b)(6) 2014, the patient was brought to operating room, and under spinal anesthesia he had a removal of left knee wound vac, removal of hardware left total knee, with insertion of antibiotic cement spacer.Post-operatively, the patient had anemia, pneumonia, metabolic encephalopathy.It was further reported that the patient was discharged on (b)(6) 2014.No additional information was provided.

• Brand Name: ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4842200
• MDR Text Key: 5944296
• Report Number: 2210968-2015-07047
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2015
• 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): Death; Required Intervention
• Patient Weight: 120