MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ORTHOPEDIC SALVAGE SYSTEM 3CM DIAPHYSEAL SEGMENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant devices - orthopedic salvage system modular proximal tibial body 9cm catalog #: 161027 lot #: 510700, orthopedic salvage system 7cm diaphyseal segment catalog #: 150466 lot #: 013430.Report source - foreign: (b)(6).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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, 0001825034-2020-04218.Investigation incomplete.
Event or Problem 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.
Additional Manufacturer Narrative
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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ORTHOPEDIC SALVAGE SYSTEM 3CM DIAPHYSEAL SEGMENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11046348
• Report Number: 0001825034-2020-04387
• Device Sequence Number: 1034017
• Product Code: JDI
• UDI-Device Identifier: 00880304239852
• UDI-Public: (01)00880304239852
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2026
• Device Model Number: N/A
• Device Catalogue Number: 150464
• Device Lot Number: 517270
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1