MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CPS RIGHT 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infiltration into Tissue (1931); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Ambulation Difficulties (2544)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02857, 0001822565-2019-02858, and 0001822565-2019-02859.Concomitant medical products: unknown zimmer ps femoral catalog#: ni lot#: ni, unknown zimmer ps tibial tray catalog#: ni lot#: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent right total knee arthroplasty.The surgeon expected to do a cruciate retaining knee, but realized that he would instead need to do a posterior stabilized knee.A posterior stabilized knee kit was not available nearby, so the patient was kept under anesthesia for twelve (12) hours while a posterior stabilized kit was retrieved.Patient is now reporting pain, difficulty walking, and nerve damage.No revision procedure has been reported at this time.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00230, 0001822565-2019-02858, 3007963827-2019-00232, and 0002648920-2019-00587.Concomitant medical products- femur cemented posterior stabilized (ps) standard right size 11 catalog#: 42500607002 lot#: 63702220, tibia cemented 5 degree stemmed right size f catalog#: 42532007502 lot#: 63682842, all poly patella cemented 29 mm diameter catalog#: 42540000029 lot#: 63695650.

Event Description

It was reported that patient underwent right total knee arthroplasty.The surgeon expected to do a cruciate retaining knee, but realized that he would instead need to do a posterior stabilize knee as he did get the expected flexion and extension intra operatively despite of additional bone removal from tibia.A posterior stabilize knee kit was not available nearby, so the patient was kept under general aesthesia for twelve (12) hours while a posterior stabilized kit was retrieved.Patient is now reporting pain, numbness, non functioning joint, and nerve damage.No revision procedure has been reported at this time.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.No medical records were received.Device history record (dhr) was reviewed and no discrepancies were found.Per the package insert, pain and nerve damage are known potential adverse effects of this procedure.A definitive root cause cannot be determined.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

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

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h10.Reported event was confirmed by review of medical records.Primary operative states no intra-operative complication, however there was delay in surgery for more than 3 hrs.Office visit notes patient has pain and had to use a cane since his right knee replacement and has about a 10 degree flexion contracture.Patient's leg is numb from the thigh down from his total knee arthroplasty and patient says his total knee arthroplasty feels unstable.Patient had an office visit for neuropathy that resulted from the surgery.X-ray review by third party health care professional states three views of the right knee demonstrate a right total knee arthroplasty without significant radiolucency.No bony fracture.No significant joint effusion.Root cause was unable to be determined.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CPS RIGHT 12 MM HEIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8767129
• MDR Text Key: 150250877
• Report Number: 0001822565-2019-02858
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 42522600812
• Device Lot Number: 63435556
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE NARRATIVE IN H10
• Patient Outcome(s): Other
• Patient Weight: 108