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

Model Number N/A

Device Problems Unstable (1667); Insufficient Information (3190)

Patient Problems Damage to Ligament(s) (1952); Pain (1994); No Information (3190)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Medical products: kne-other-tibial tray-unk, p/n: unk, l/n: unk; kne-other-femorals-unk, p/n: unk, l/n: unk; kne-other-bearing-unk, p/n: unk, l/n: unk.Customer has not indicated that the product will 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.Product location is unknown.

Event Description

It was reported the patient had a revision procedure on an unknown date due to unknown reasons.Subsequently, the tibial tray component was revised.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.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.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 - 2019 - 04152, 0001825034 - 2019 - 04153, 0001825034 - 2019 - 04154.

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, d4, d11, g4, g7.Additional: h1, h2, 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.

Event Description

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

Manufacturer Narrative

Udi # (b)(4).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.

• Brand Name: BIOMET CC CRUCIATE TRAY
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8860359
• MDR Text Key: 153253123
• Report Number: 0001825034-2019-03380
• Device Sequence Number: 1
• Product Code: HRY
• 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,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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: 141232
• Device Lot Number: J3778628
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Weight: 100