MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM MODULAR PROXIMAL TIBIAL BODY 9CM; PROSTHESIS, KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: orthopedic salvage system 7cm diaphyseal segment catalog #: 150466 lot #: ni, orthopedic salvage system femoral diaphyseal coupler 30cm catalog #: 150463 lot #: ni report source: (b)(6).The complainant 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 patient; please see all reports associated with this event: 0001825034-2020-04217.

Event Description

It is reported that during a knee arthroplasty revision to address unrelated reasons, the surgeon attempted to adjust the tibial length.However, after removing the screws between the tibial body and diaphyseal segment, the surgeon was unable to disengage the implant taper lock.The surgery was completed without extending the tibial length and it is unknown whether an additional surgery has been planned, however, the surgeon has requested further instructions in order to lengthen the tibia at a later date.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product- orthopedic salvage system 7cm diaphyseal segment catalog #: 150466 lot #: 013430, orthopedic salvage system 3cm diaphyseal segment catalog #: 150464 lot #: 517270.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001825034-2020-04217, 0001825034-2020-04387.

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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review, however, the reported event could not be confirmed.Photographs were provided, which showed the intraoperative site with the tibial body connected to the diaphyseal segment.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.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM MODULAR PROXIMAL TIBIAL BODY 9CM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10905786
• MDR Text Key: 218497477
• Report Number: 0001825034-2020-04218
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K051479
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 161027
• Device Lot Number: 510700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 04/23/2021
• Supplement Dates FDA Received: 12/21/2020; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1