MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNI KNEE TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unknown, unknown femoral component, unknown.Unknown, unknown bearing, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-06442.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

It was reported that the patient underwent right partial knee procedure.Subsequently, the patient was revised to a total knee due to pain and loosening.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.The following sections were updated: (b)(6).Report date.Describe event or problem - it was reported that the patient underwent right partial knee procedure.Subsequently, the patient experienced pain approximately three months post-implantation.Subsequently, the patient was revised to a total knee due to pain, stiffness, and loosening.No additional patient consequences were reported.Relevant tests/lab data - radiographs evaluated on (b)(6) 2017 revealed a failed medial uni with subsidence of the tibial component.Femoral component is in good position.Intraoperative frozen consultation report taken on (b)(6) 2017 noted mildly hyperplastic synovial tissue demonstrating occasional lymphoid and histiocytic infiltrates; no evidence of acute inflammation.(b)(6).Health professional? - yes.Occupation - physician.Date received by mfr - oct 13, 2017.Type of reports.If follow-up, what type? - additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent right partial knee procedure.Subsequently, the patient experienced pain approximately three months post-implantation.Subsequently, the patient was revised to a total knee due to pain, stiffness, and loosening.No additional patient consequences were reported.

Manufacturer Narrative

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

It was reported that the patient was revised due to tibial loosening.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown a the time of the initial medwatch.Medical products: articular surface catalog # 00584202210 lot # 60372637; femoral component catalog # 00584201402 lot # 61272161; palacos catalog # 00111314001 lot # unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed through review of medical records.The returned tibial component exhibited signs of wear of the inferior and superior surfaces with remains of bone cement on the superior surface.The device history records were reviewed and no deviations relevant to the reported event were identified.Office visit notes from the patient's medical records indicate that the patient was suffering from acute knee pain.Radiographic inspection identified subsidence of the tibial component.Revision operative notes report that the tibial component was found to be loose.Per the package insert for the unicompartmental knee, loosening, pain and stiffness are known adverse effects of total knee arthroplasty.However, 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.

• Brand Name: ZIMMER UNI KNEE TIBIAL COMPONENT
• 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: 6865730
• MDR Text Key: 86158823
• Report Number: 0001822565-2017-06443
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/27/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00584200202
• Device Lot Number: 60923150
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 11/21/2017; 02/05/2018; 09/18/2018
• Supplement Dates FDA Received: 11/09/2017; 12/21/2017; 02/27/2018; 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR