MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 71MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Pain (1994); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651)

Event Date 03/23/2022

Event Type  Injury  

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 patella.Mdr: 0001825034-2022-01136.Unk bearing.Mdr: 0001825034-2022-01137.

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.

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.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.Revision surgery notes state that scar tissue was removed from medial and lateral gutters.Polyethylene was quite thick, no gross damage.The femoral implant was removed quite easily and patient had significant stress shielding bone below the implant, condyles were intact but had contained defects within each.Tibial component was removed using oscillating saw, there was very little bone loss and there was no cement on the tibial keel (loss of fixation).The distal femoral bone remnant in the condyle was very poor quality- it left no doubt that significant augmentation of the femoral cone would be needed to allow good fixation.X-ray review revealed tibial component loosening with excessive posterior slope.X-ray review(2) left knee demonstrates subsidence of the medial tibial component and femoral component appears preserved.This complaint is confirmed.Root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: BIOMET CC CRUCIATE TRAY 71MM
• 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 ; .; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14304412
• MDR Text Key: 290934706
• Report Number: 0001825034-2022-01135
• 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: 08/22/2022

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: 09/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 141233
• Device Lot Number: J3126064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• 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 Sex: Female
• Patient Weight: 75 KG