MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT SIZE 3 RIGHT; PROSTHESIS KNEE

Model Number N/A

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product is not returned to zimmer biomet.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 partial patella femoral procedure and was revised due to pain and burning sensation.Also the implant not seated properly.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The products were 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 the gender solutions pfj package insert, pain and malalignment are known potential adverse effects of this procedure.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant products- concomitant devices - nexgen all poly patella size 29mm catalog #: 00597206529 lot #: 62413061.Multiple mdr reports were filed for this patient, please see all reports associated with this event: 0001822565-2017-08332; 0002648920-2018-00768.

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address pain, a burning sensation and improper seating of the prostheses approximately four years post-operatively.No additional patient consequences were reported.

• Brand Name: GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT SIZE 3 RIGHT
• 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: 7087849
• MDR Text Key: 93882116
• Report Number: 0001822565-2017-08332
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00592601302
• Device Lot Number: 62314704
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2013
• 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: 40 YR
• Patient Weight: 83