MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET CRUCIATE TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); No Information (3190)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vanguard posterior stabilized bearing, catalog #: ep-183660, lot #: 173580, vanguard interlock femoral, catalog #: 183132, lot #: j3655102, patella, catalog #: 184764, lot # 056770.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-02146.Product location unknown.

Event Description

It was reported that the patient underwent a left knee arthroplasty.Subsequently, the patient was revised due to malposition of tibial prosthesis and dislocation of the patella.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Ep-183660 e1 vngd ps tib brg 79/83x10 173580.00111214001 palacos r 1x40 single 81454445.00111314001 palacos rg 1x40 single 81824426.183132 van ps open intl fem-lt 70 j3655102.Reported event was confirmed by review of the provided x-rays and op notes.Review of pre-revision follow-up records noted patient experiencing pain with activities and instability.Dislocation of the patella and also noted that there is no gross malrotation on the femoral side but there might be internal rotation on the tibial side.X-rays provided were sent to hcp for review.It was noted that the patellar component which demonstrated severe lateral subluxation versus dislocation.Dhr was reviewed and no discrepancies relevant to the reported event 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: BIOMET CRUCIATE TIBIAL TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7363941
• MDR Text Key: 103267874
• Report Number: 0001825034-2018-02045
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK915132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 141235
• Device Lot Number: J3646481
• Other Device ID Number: (01) 00880304008342
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 04/20/2018
• Supplement Dates FDA Received: 04/23/2018
• 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 Age: 67 YR
• Patient Weight: 105