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

Catalog Number 00584201402

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00584200202, tibial component precoat right medial/left lateral size 2, lot # 60328072.Catalog #: 00584305201, tibial tray / articular surface inserter tip, lot # 60455933.Catalog #: 00584202209, articular surface size 2 9 mm height femoral size a,b,c,d,e,f,g, lot # 60286187.Catalog #: 00579104100, headed screw 48 mm length single use only, lot # 60680747.Catalog #: 00579104400, headed screw 33 mm length, lot # 60656749.The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-04849, 04855, and 04857.

Event Description

It was reported that the patient experienced pain and swelling after a right total knee arthroplasty.

Manufacturer Narrative

(b)(4).The follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient experienced pain, cysts, and swelling after a right total knee arthroplasty that she received after walking weirdly from a right hip replacement in which the doctor had to correct her leg length.Patient also gets cramps in her toes on the right leg.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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.

• Brand Name: FEMORAL COMPONENT HIGH FLEX PRECOAT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6712271
• MDR Text Key: 80010629
• Report Number: 0001822565-2017-04814
• 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,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 00584201402
• Device Lot Number: 60643098
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2007
• 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): Required Intervention
• Patient Weight: 61