MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET TIBIAL LOCKING BAR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 04/16/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products.Concomitant medical products: 185108, ps tibial bearing, 934200, vanguard femoral augment 185348 lot 718040, vanguard femoral 185288 lot 3833410, vanguard posterior femoral augment 185428 lot 613230, biomet tibial tray 185205 lot 127270, vanguard distal femoral augment 185388 lot 921890, biomet stem 145026 lot 772760, biomet stem 145026 lot 118460, tibial cruciate wing 185651 lot 079420, 92-2010, calcigen 3, 625150, 348014, calcigen s bone graft system, 834560.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient presented with pain post left knee arthroplasty and after x-rays were taken the locking bar was found to have backed out into the patient's soft tissue.Patient underwent a revision approximately four months post implantation; the locking bar and tibial bearing were removed and replaced.

Manufacturer Narrative

The reported event was confirmed by a review of the inoperative photos which clearly demonstrates the locking bar in the soft tissue of the knee.It can be implied that this is the source of the patient's pain.The patient's poly bearing and locking bar have been replaced.Inspection of the returned device showed wear.The bearing component also showed wear marks on the surface of the device.Device history record was reviewed and no discrepancies relevant to the reported event were found.Analysis of the locking bar determined that the locking bar contact mark & deformation observations are consistent with the bar not being fully engaged with the tibial tray.However, it cannot be confirmed with certainty whether the reported locking bar dissociation occurred due to improper insertion.The root cause was unable to be determined.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

The following report is being submitted to relay the corrected information.The correction made does not change any investigation results.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 additional information is available to report at this time.

• Brand Name: BIOMET TIBIAL LOCKING BAR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7514540
• MDR Text Key: 108267207
• Report Number: 0001825034-2018-03310
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: PK171054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2019

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: 141205
• Device Lot Number: 944480
• Other Device ID Number: (01) 0088030400973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 01/15/2019; 02/06/2019
• Supplement Dates FDA Received: 01/17/2019; 02/13/2019
• 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: 70 YR