MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ROTATING HINGE KNEE FEMORAL COMPONENT SIZE D; PROSTHESIS, KNEE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient was born in 1949.Concomitant medical products: unknown rotating hinge knee femoral stem 13x155mm: catalog#ni, lot#ni; unknown rotating hinge knee tibial component gr3: catalog#ni, lot#ni; unknown rotating hinge knee tibial stem 10x100: catalog#ni, lot#ni; unknown nexgen articular surface 12mm: catalog#ni, lot#ni; unknown nexgen patella gr 35: catalog#ni, lot#ni; unknown cement: catalog#ni, lot#ni.Foreign source: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2022-02635.Customer has indicated that the product will not be returned for evaluation as the product has not been returned by the patient.The investigation is in process.Upon completion of the investigation or receipt of additional information, a follow up mdr report will be submitted.

Event Description

It was reported that a patient underwent a total knee arthroplasty.Approximately seven years post implantation, without an external event or trauma, the patient began to experience pain in the knee.Xray images revealed that the femoral stem had fractured and one week after pain onset, the patient was revised.During the surgery, a periprosthetic femur fracture was also noted which was repaired with a cable cerclage fixation procedure.The femoral stem, femoral component, and articular surface were replaced.Due diligence is complete as multiple attempts have been made; no further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: medical product: stem extension straight long 13mm dia x 155mm length: catalog#00598801113, lot#62729931; unknown rotating hinge knee tibial component gr3: catalog#ni, lot#ni; unknown rotating hinge knee tibial stem 10x100: catalog#ni, lot#ni; articular surface with hinge post extension size d 12 mm height: catalog#00588004012, lot#62945222; unknown nexgen patella gr 35: catalog#ni, lot#ni; unknown cement: catalog#ni, lot#ni.Multiple mdr reports have been filed for this event.Please see associated report: 0002648920-2022-00241.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

No further event information at time of this report.

Event Description

No further event information at time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h10.H6: proposed component code: mechanical (g04) - femur.Visual examination of the returned products identified the femoral component has bone cement on it and a section of the fractured stem remains in the connection.Due to the cement, product identification cannot be verified.The device was submitted for further analysis.Analysis determined the fracture surface artifacts of beach marks are consistent with the fatigue failure mode.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient presents with pain in the right knee joint that has been going on for weeks; implant fracture with cone fracture and supracondylar femur fracture; the distal femur condylar fragment was freed and removed, osteotomy performed and fracture extends 3cm upon removal of cement, secured with cable cerclage.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fracture of the femoral stem of the right knee arthroplasty; implant alignment is maintained root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN ROTATING HINGE KNEE FEMORAL COMPONENT SIZE D
• Type of Device: 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: 15639141
• MDR Text Key: 302079837
• Report Number: 0001822565-2022-02989
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female