MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL HIGH FLEX PRECOAT FEMORAL COMPONENT SIZE F; PROSTHESIS, KNEE

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products- zimmer unicompartmental knee precoat tibial component size 4 catalog #: 00584200402 lot #: 61927336, zimmer unicompartmental knee articular surface size 4 11mm catalog #: 00584202411 lot #: 61443855, headed screw 48mm catalog #: 00579104100 lot #: 62208598, headed screw 33mm catalog #: 00579104400 lot #: 62203456.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.Per package insert for unicompartmental knees, pain, noise, and limited physical activity are known potential adverse effects associated with the surgical procedure.However, 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.Multiple mdr reports were filed for this patient; please see all reports associated with this event.0001822565-2019-00999, 0001822565-2019-04800, 0001822565-2019-04801.

Event Description

It is reported that the patient underwent a left knee arthroplasty revision to address pain, popping in the knee and limited physical abilities approximately six (6) years post-operatively.No additional patient consequences have been reported.

• Brand Name: ZIMMER UNICOMPARTMENTAL HIGH FLEX PRECOAT FEMORAL COMPONENT SIZE F
• 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: 9306264
• MDR Text Key: 166126157
• Report Number: 0001822565-2019-04800
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00584201602
• Device Lot Number: 61928542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2011
• 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: 56 YR