MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CR STANDARD POROUS; PROSTHESIS, KNEE

Model Number	42-5028-062-02
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study that a patient underwent a primary total knee arthroplasty.Approximately one year post implantation, the patient was revised due to instability.All components were exchanged without incident.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface fixed bearing cruciate retaining (cr) right 14 mm height: catalog#42521000414, lot#63003588; natural tibia trabecular metal two-peg porous fixed bearing right size d: catalog#42530006702, lot#77007674; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#64180994; optipac 40 refob bone cmt r-3: catalog#4710500394-3, lot#811aa07110.Report source: foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated report: 0002648920-2021-00465.Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: articular surface fixed bearing ultracongruent (uc) right 20 mm height: catalog#: 42521200420, lot#: 63727338.The associated report was filed under an incorrect mfr number.It has been re-filed under mdr: 3007963827-2022-00052.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported via a clinical study that a patient underwent a primary total knee arthroplasty.Approximately one year post implantation, the patient was revised due to instability.The femoral and tibial components and articular surface were exchanged without incident.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.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.
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.The following sections have been updated: b4; b5; g3; h2; h3; h6; h10.Device history record review was not performed as the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.The patient had an initial total knee arthroplasty one year prior to the reported event as well as prior surgeries to this knee that consisted of menisci removal and ligament reconstruction due to sports injuries.There have been two revisions to this knee due to instability with the first being a poly exchange and the second a revision total knee arthroplasty.The patient¿s anatomy from the previous surgeries to the meniscus and ligaments can cause issues with stability.The meniscus provides shock absorber, load transmission, joint stability, proprioception (quick-adapting mechanoreceptors), and lubrication of the knee.They sit inside and outside of the knee and distribute the load from the thigh bone to the shin bone.The ligaments of the knee are found inside and outside of the knee.There are the cruciate ligaments that control the back-and-forth motion, and the collateral ligaments control the sideways motion and is a brace against unusual movement.With these being previously reconstructed and removed the patient can experience instability.Upon further review of this information and history, the root cause of the reported event can be attributed to non-device related factors.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.H3 other text : see h10 narrative.
Event or Problem Description
No further event information at time of this report.

• Brand Name: FEMUR TRABECULAR METAL CR STANDARD POROUS
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13203553
• Report Number: 0001822565-2021-03720
• Device Sequence Number: 14517474
• Product Code: MBH
• UDI-Device Identifier: 00889024230767
• UDI-Public: (01)00889024230767(17)260731(10)63417270
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2022

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 Expiration Date: 07/31/2026
• Device Model Number: 42-5028-062-02
• Device Catalogue Number: 42502806202
• Device Lot Number: 63417270
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 02/01/2022; 03/23/2022; 05/10/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/22/2022; 03/25/2022; 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• 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.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG