MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN IM NAIL; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Bone Fracture(s) (1870); Hypovolemia (2243); Blood Loss (2597)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was unable to be performed as the lot number of the device involved in the event is unknown.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: 3 weeks post spacer placement.Patient went to rehab.Femur is abnormally mobile.Bends and extends in flexion in a way it should not as she has a knee fusion nail in place.No pain.Patient has no recollection of an injury however has extreme short term memory issues secondary to stroke.Wound discoloration and in the medial and lateral aspect about the incision site consistent with history of infection and repeat operation, no signs of acute inflammation.Closed displaced comminuted fracture of shaft of right femur.Undetermined cause.Husband states that it has been unstable since she was discharged from the rehab hospital.Admitted urgently to hospital for revision following day with long fusion nail.Removal of static spacer and placement of knee fusion nail from hip to ankle op note.Right femur supracondylar fracture with intercondylar extension-unknown etiology.No evidence of active infection.Large body habitus complicated approach making it larger and deeper than usual.Poorly healed scar.Reamed up to a 13.5 diameter implant for 11.5 nail.The knee joint was accessed through a lateral parapatellar approach as this area had already been disrupted in majority by sharp bone fragments of the proximal femur.Antibiotic spacer removed.Zimmer trabecular metal cone placed to protect tibia from further injury.Estimated blood loss was significant, 1000 ml because no tourniquet was possible due to the patient¿s thigh size.2 units administered and additional 250 ml of cell saver returned.This blood loss would be anticipated as the use of tourniquet was not possible.Cell saver was utilized to aid in replacing blood loss.Patient¿s pre-existing conditions, anatomy, and comorbidities all factor in to inability to use tourniquet, complicated femur fracture and obesity would preclude patient to experience intra-op blood loss.The root cause is attributed to patient condition/comorbidities.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

 it was reported the patient underwent a revision procedure approximately 15 days post implantation due to infection and wound dehiscence.The implants were removed and a static spacer was implanted as well as an im nail.Subsequently, the nail and spacer were removed and a competitor fusion nail was placed, due to a closed displaced comminuted fracture of shaft of right femur of unknown etiology.During the procedure the patient had an estimated blood loss of 1000 ml as a tourniquet could not be used due to the patient¿s thigh being too large for the cuff.The patient received 2 units of blood and also 250 ml of cell saver returned to patient.

• Brand Name: UNKNOWN IM NAIL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11037621
• MDR Text Key: 222352373
• Report Number: 0001822565-2020-04163
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

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: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/18/2020
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 106