MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT SIZE C LEFT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - concomitant devices - zimmer segmental articular surface with segmental hinge post size c 12mm catalog #: 00585003012 lot #: 66068983, zimmer segmental polyethylene insert xt size c catalog #: 00585001396 lot #: 66068979, nexgen fluted stem extension straight precoat 8mm x 130mm catalog #: 00585205009 lot #: 65617232, zimmer segmental proximal tibial component size 3 catalog #: 00585000310 lot #: 63859283, nexgen standard all poly patella size 38mm catalog #: 00597206538 lot #: 64774939, nexgen stem collar 35mm catalog #: 00585204035 lot #: 65466071, nexgen fluted stem extension straight precoat 11mm x 130mm catalog #: 00585205011 lot #: 65055137, nexgen stem collar 25mm catalog #: 00585204025 lot #: 65530735 g2 - report source - foreign: the event occurred in australia.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.
Event or Problem Description
It was reported that the patient underwent an above knee leg amputation approximately nine (9) months following left knee arthroplasty to address dislocation of the hinge.Attempts have been made; however, no additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.The following sections were corrected: h4 h6 - component code - proposed code is mechanical (g04) - femur review of radiographs provided confirmed dislocation of the left total knee arthroplasty at the hinge.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: ZIMMER SEGMENTAL DISTAL FEMORAL COMPONENT SIZE C LEFT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19905869
• Report Number: 0001822565-2024-02556
• Device Sequence Number: 18325816
• Product Code: KRO
• UDI-Device Identifier: 00889024195943
• UDI-Public: (01)00889024195943(17)330826(10)66069012
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00585004301
• Device Lot Number: 66069012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 64 KG