MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VNGD PS+ TIB BRG 14X71/75MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273); Migration (4003)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported an initial left total knee arthroplasty, performed.Subsequently, the patient underwent a revision nine years post procedure, due to pain and loosening.No further complications were reported.

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Additional associated products & mdrs: unk femoral component, mdr: 0001825034-2022-01134; unk tibial component, mdr: 0001825034-2022 -01135; unk patella, mdr: 0001825034-2022-01136.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Additional associated products & mdrs please note it was determined during investigation of the reported event, that the part referenced in the associated product mdr: 0001825034-2022-01136, should not have been reported.The initial report for mdr: 0001825034-2022-01136 has been voided.

Event Description

It was reported the patient had an initial left total knee arthroplasty.Subsequently, the patient underwent a revision approximately 9 years post procedure, due to pain and loosening.During revision, scar tissue was removed and subsidence and loss of fixation were noted related to the tibia.The patient was also found to have poor femoral bone quality.The revision system was placed in an acceptable manner and no further complications were reported.

Event Description

Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information found during investigation of the reported event, it was determined that the part referenced should not have been reported.The initial report should be voided.

• Brand Name: VNGD PS+ TIB BRG 14X71/75MM
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14304753
• MDR Text Key: 290924049
• Report Number: 0001825034-2022-01137
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 183744
• Device Lot Number: 337980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 75 KG