MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 14MM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown orthopedic salvage system tibial bushing catalog #: ni lot #: ni, unknown orthopedic salvage system yoke catalog #: ni lot #: ni, unknown orthopedic salvage system lock pin catalog #: ni lot #: ni, unknown orthopedic salvage system axle catalog #: ni lot #: ni, unknown orthopedic salvage system femoral bushings catalog #: ni lot #: ni, unknown screws catalog #: ni lot #: ni, unknown orthopedic salvage system femoral component catalog #: ni lot #: ni, orthopedic salvage system 7cm diaphyseal segment catalog #: 150466 lot #: ni, orthopedic salvage system modular proximal tibial body 9cm catalog #: 161027 lot #: ni, orthopedic salvage system femoral diaphyseal coupler 30cm catalog #: 150463 lot #: ni.Report source - foreign: (b)(6).The complainant has not yet indicated whether the device will be returned to zimmer biomet for evaluation.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 patient; please see all reports associated with this event: 0001825034-2020-04176, 0001825034-2020-04180.

Event Description

It is reported that the patient underwent a knee arthroplasty revision to address post-operative metallosis and implant fracture of the yoke and tibial bearing approximately six (6) years post-operatively.Attempts have been made and no additional information is available at this time.

Event Description

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

Manufacturer Narrative

This follow-up report is being filed to relay additional and corrected information.

Manufacturer Narrative

Visual examination of the provided picture found the yoke tabs have fractured off and the bearing hard fractured near the yoke tables.There is also metallosis seen in the joint space.Dhr was reviewed and no discrepancies were found.The root cause is 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.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM RS LS TIBIAL BEARING 14MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10896070
• MDR Text Key: 218009557
• Report Number: 0001825034-2020-04176
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K052685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 161095
• Device Lot Number: 426400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• 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