MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPAEDIC SALVAGE SYSTEM AXLE; PROSTHESIS, KNEE

Model Number N/A

Device Problems Unstable (1667); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 07/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - orthopaedic salvage system poly lock pin catalog #: 150478 lot #: 395950, orthopaedic salvage system 4cm diaphyseal segment catalog #: 150482 lot #: 640430, orthopaedic salvage system cemented im stem 15mm x 150mm catalog #: 150369 lot #: 055900, orthopaedic salvage system 7cm segmental femoral component right catalog #: 150354 lot #: 782310, orthopaedic salvage system modular tibial baseplate 79mm catalog #: 150424 lot #: 689560, series a 3 peg patella thin 37mm x 8.6mm catalog #: 184788 lot #: 277320, orthopaedic salvage system polyethylene tibial bearing 16mm catalog #: 150412 lot #: 622440, orthopaedic salvage system reinforced yoke catalog #: 150493 lot #: 293580, orthopaedic salvage system polyethylene femoral bushings catalog #: 150477 lot #: 096430, orthopaedic salvage system polyethylene tibial bushing catalog #: 150476 lot #: 540910.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the devices were discarded.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: 0001825034-2023-01892, 0001825034-2023-01896, 0001825034-2023-01897, 0001825034-2023-01898, 0001825034-2023-01899, 0001825034-2023-01900, 0001825034-2023-01901, 0001825034-2023-01903, 0001825034-2023-01904, 0001825034-2023-01906.H3 other text : investigation incomplete.

Event Description

It was reported that the patient underwent a right knee arthroplasty revision to address post-operative instability and bone preservation.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information 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.

Event Description

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

• Brand Name: ORTHOPAEDIC SALVAGE SYSTEM AXLE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17555756
• MDR Text Key: 321229916
• Report Number: 0001825034-2023-01905
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 00880304002487
• UDI-Public: (01)00880304002487(17)280722(10)942420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 150480
• Device Lot Number: 942420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male