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

Model Number N/A

Device Problems Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Joint Laxity (4526)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated products : item#: 402282, cobalt hv bone cement 40g; lot#: 110970.Item#: 402282, cobalt hv bone cement 40g; lot#: 110920.Item#: 184766, series a pat std 34 3 peg; lot#: 088880.Item#: 183106, van ps open intl fem-rt 62.5 ; lot#: 357760.Item#: 183642, vngd ps tib brg 12x71/75mm; lot#: 642800.Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review found right knee revision due to pain.Loose tibial component from cement mantle with mild laxity of ligament, but not overly unstable.Removed poly and locking pin.Femoral implant and patella well fixed and were not removed.Tibia component was subluxed forward and removed easily (loose).No complications noted.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01074, 0001825034-2021-01075.

Event Description

Legal reported primary right tka performed approximately 7 years ago.Subsequently, it was reported right revision of total knee 1.5 years ago due to pain, tibial loosening and instability.Tibial component was subluxed forward and easily removed.

Manufacturer Narrative

Once the investigation has been completed, an additional follow-up mdr will be submitted.

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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review found patient experienced a fall while kicking a ball.Slight laxity in 30 degrees of flexion mcl and lcl 90 degrees good ap stability.Nm bone scan uptake increase right tibial plateau, specific to lateral.Right knee revision due to pain and tibial loosening.Loose tibial component from cement mantle with mild laxity of ligament, but not overly unstable.Removed poly and locking pin.Femoral implant and patella well fixed and were not removed.Tibia component was subluxed forward and removed easily (loose).No complications noted.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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
• MDR Report Key: 11716384
• MDR Text Key: 260495992
• Report Number: 0001825034-2021-01216
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 141233
• Device Lot Number: J3341495
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79