MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD ANTERIOR STABLIZD BEARING; PROSTHESIS, KNEE

Catalog Number 189042

Device Problem Unstable (1667)

Patient Problems Damage to Ligament(s) (1952); Pain (1994)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Concomitant medical products: biomet cc cruciate tray 67mm; p/n: 141232, l/n: unk; vngd ant stblzd brg 12x67; p/n: 189042, l/n: unk; vanguard cr ilok fem-rt 67.5; p/n: 183010, l/n: unk; series a pat std 31 3 peg; p/n: 184764, l/n: unk; palacos r 1x40 single; p/n: 00111214001, l/n: unk, qty: 2.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03380 - 1, 0001825034 - 2019 - 04153, 0001825034 - 2019 - 04154.Product location is unknown.

Event Description

It was reported patient underwent a revision procedure due to pain and instability approximately six months post implantation.Subsequently, ligament laxity was noted during the revision.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated via medical records and the reported event was confirmed.Medical records were provided and reviewed by a health care professional.Patient underwent an initial right total knee arthroplasty with no complications noted.Patient was revised due to pain and instability with no complications noted.Surgeon was unable to achieve adequate stability by upsizing bearing alone, femoral and tibial components were revised.Ligament laxity was noted.Patient's claim of defective tibial tray was not confirmed by intraoperative findings.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, g4, g7.Additional: h1, h2, h3, h6, h10.Dhr was reviewed and no discrepancies were found.This new information does not affect the previously completed investigation.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Updated: a5, b4, b5, d4, d11, g4, g7.Additional: h1, h2, h4, h10.D11 medical products: biomet cc cruciate tray 67mm; p/n: 141232, l/n: j3778628 vngd ant stblzd brg 12x67; p/n: 189042, l/n: 108580 vanguard cr ilok fem-rt 67.5; p/n: 183010, l/n: j3733293 series a pat std 31 3 peg; p/n: 184764, l/n: 693590 palacos r 1x40 single; p/n: 00111214001, l/n: unk qty: 2.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: VANGUARD ANTERIOR STABLIZD BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9092271
• MDR Text Key: 159283306
• Report Number: 0001825034-2019-04152
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K113550
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 189042
• Device Lot Number: 108580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 100