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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 10/11/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 to address loosening.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: concomitant devices - unknown zimmer tibial component catalog #: ni lot #: ni, unknown zimmer articular surface catalog #: ni lot #: ni the product was evaluated through review of manufacturing records, however the reported event could not be confirmed.The device history records were reviewed and no discrepancies were identified.Per the package insert for the gender solutions patello-femoral joint, loosening is one of the adverse effects of total knee arthroplasty.However, a definitive root cause cannot be determined due to insufficient 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 event; please see all reports associated with this event.0001822565-2017-06372 0001822565-2018-04856.

• Brand Name: GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA 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: 6864204
• MDR Text Key: 86085206
• Report Number: 0001822565-2017-06372
• Device Sequence Number: 1
• Product Code: KRR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00592601301
• Device Lot Number: 61408743
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2010
• 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: 59 YR
• Patient Weight: 66