MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CC CRUCIATE TRAY 75MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Unstable (1667); Migration (4003)

Patient Problems No Information (3190); Joint Laxity (4526)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: van ps open intl fem-rt 65, catalog # 183108, lot # j3737946.Vngd ps+ tib brg 14x71/75mm, catalog # 183744, lot # 587560.Series a asymmetric pat 34x8.5, catalog # 184793, lot # 614580.Palacos rg 1x40 single, catalog # 00111314001, lot # 83304476.Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001825034-2020-03991.

Event Description

It was reported that the patient underwent a knee arthroplasty.Subsequently, the patient was revised due to aseptic loosening.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D4 - udi #: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies were found.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.

Event Description

From additional information received, it was reported that the patient underwent a revision due to instability.During the revision procedure, it was noted that the tibial tray prosthesis was found grossly loose and medial side of implant had subsided.The tibial tray and polyethylene bearing were removed and replaced.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records provided.Additional information does not affect the previous root cause.Medical records for revision review indicates that tibial tray grossly loose & subsided medially.There was some laxity seen.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 75MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10784258
• MDR Text Key: 214520536
• Report Number: 0001825034-2020-03989
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K142933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 141234
• Device Lot Number: J3851571
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/04/2020; 12/09/2020; 03/09/2021
• Supplement Dates FDA Received: 12/08/2020; 12/29/2020; 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 85