MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET 360 TIBIAL CRUCIATE WING; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Rheumatoid Arthritis (1724); Death (1802); Staphylococcus Aureus (2058)

Event Date 11/14/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: series-a standard patella 34mm x 8.5mm catalog #: 184766 lot #: 409610, biomet splined knee stem v2 with screw 18mm x 40mm catalog #: 148293 lot #: 269100, vanguard ssk 360 femoral component left 72.6mm catalog #: 185287 lot #: 6053604, biomet 360 offset adapter with screws 7.5mm catalog #: 185212 lot #: 289130, vanguard 360 revision posterior augment with bolt 5mm x 72.5mm catalog #: 185347 lot #: 862360, vanguard 360 revision distal femoral augment with bolt 5mm x 72.5mm catalog #: 185307 lot #: 186000, biomet 360 tibial tray 79mm catalog #: 185205 lot #: 883210, biomet 360 offset adapter 2.5mm catalog #: 185210 lot #: 371710, biomet 360 tibial augment 10mm x 79mm catalog #: 185235 lot #: 830830, biomet splined knee stem v2 with screw 17mm x 40mm catalog #: 148292 lot #: 945540, vanguard posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 449000, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 237190, biomet tibial locking bar catalog #: 141205 lot #: 966260, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 055590, biomet tibial locking bar catalog #: 141205 lot #: 478950, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 018270, biomet tibial locking bar catalog #: 141205 lot #: 889430, vanguard ssk posterior stabilized tibial bearing 12mm x 79/83mm catalog #: 185102 lot #: 018270, biomet tibial locking bar catalog #: 141205 lot #: 588070, tibial knee cement mold 80mm catalog #: 433180 lot #: 014870, femoral knee cement mold 70mm catalog #: 432170 lot #: 202630.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the location of the device remains unknown at this time.Review of the device history records identified no related deviations or anomalies during manufacturing.Review of the sterile certificates indicates that the products were sterile when they were released from zimmer biomet control.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2018-10745, 0001825034-2018-10746, 0001825034-2018-10747, 0001825034-2018-10748, 0001825034-2018-10749, 0001825034-2018-10750, 0001825034-2018-10751, 0001825034-2018-10752, 0001825034-2018-10753, 0001825034-2018-10754, 0001825034-2018-10755, 0001825034-2018-10756.

Event Description

It was reported the patient underwent left total knee arthroplasty and developed a (b)(6) infection three (3) weeks post-operatively.The patient underwent multiple polyethylene bearing replacements with irrigation and debridement procedures.As the infection continued, the patient underwent a knee arthroplasty revision and spacer molds were implanted.It was noted during the revision procedure that the patient had necrosis on the incision as well as the patella.Approximately three weeks later, the patient underwent a below the knee amputation.Six days following the amputation, the patient exhibited rheumatoid arthritis in the lungs, a decrease in vital signs and expired.

Manufacturer Narrative

The product was evaluated through manufacturing review, however, the reported event could not be confirmed.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOMET 360 TIBIAL CRUCIATE WING
• 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: 8086295
• MDR Text Key: 127675840
• Report Number: 0001825034-2018-10752
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 185651
• Device Lot Number: 700880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention