MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL AUGMENT CEMENTED HALF BLOCK LEFT LATERAL SIZE CD 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	42-5558-031-05
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Osteopenia/ Osteoporosis (2651); Joint Laxity (4526)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Source foreign: (b)(6).Medical product: tibia fixed cemented left size d: catalog#42542006701, lot#64835288; tibial central cone size x-small: catalog#42545000510, lot#64800267; tibial augment cemented half block left medial size cd 5 mm thickness: catalog#42555803305, lot#65060332; stem extension straight splined uncemented 15 mm diameter +135 mm length: catalog#42560113515, lot#64925276; articular surface fixed bearing constrained condylar knee (cck) left 16 mm height: catalog#42512800416, lot#64751515; femoral central cone size medium: catalog#42545001012, lot#64597582; femur cemented standard left size 3: catalog#42504605401, lot#64862179; femoral distal augment cemented size 3, 3+ 10 mm thickness: catalog#42556605410, lot#64989015; femoral distal augment cemented size 3, 3+ 10 mm thickness: catalog#42556605410, lot#64988986; stem extension 3mm offset splined uncemented 16 mm diameter +135 mm length: catalog#42560313516, lot#64984986.Multiple mdr reports have been filed for this event, please see associated reports: 0001822565-2022-01933; 0001822565-2022-01934; 0001822565-2022-01936 and 0001822565-2022-01937.Customer is attempting to retrieve the product to return to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent a revision left total knee arthroplasty procedure.Subsequently, the patient began to experience pain, crepitus and instability.Approximately two months post-implantation, the patient underwent revision surgery.During the surgery, a tibial cortex fracture was noted which resulted in subsidence and minimal fixation of the tibial components.The tibial baseplate was also noted to have detached from the tibial stem component.Affected components were revised without reported complication.Attempts have been made and no further information has been provided.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified explanted tibial plate with biological tissue covering them.The stem was separated.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified proximal tibial fracture in post op x-ray.Subsequent tibial implant subsidence secondary to the fracture were also noted.Investigation results concluded that the reported event is attributed to user not following the instruction in the surgical technique as the surgeon accidently impacted the tibial cone implant when the cone provisional instrument was already in the bone canal.The surgical technique states to remove all provisional before implanting.Additionally, detailed steps are provided for cone bone preparation and cone implanting technique.A summary of the investigation was not sent to the complainant conveying proper surgical technique as the user was aware of the misuse during the procedure and it was corrected afterwards.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: TIBIAL AUGMENT CEMENTED HALF BLOCK LEFT LATERAL SIZE CD 5 MM THICKNESS
• 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: 14886686
• Report Number: 0001822565-2022-01935
• Device Sequence Number: 20093740
• Product Code: JWH
• UDI-Device Identifier: 00889024557123
• UDI-Public: (01)00889024557123(17)310308(10)65003438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 09/29/2022

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: 42-5558-031-05
• Device Catalogue Number: 42555803105
• Device Lot Number: 65003438
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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 H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female