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

Model Number	42-5028-074-02
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical product: unknown patellar component: catalog#ni, lot#ni; unknown medial congruent articular surface: catalog#ni, lot#ni; unknown tibial component: catalog#ni, lot#ni.Foreign: (b)(6).Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02147; 0001822565-2022-02148.The product will not be returned to zimmer biomet for evaluation, as the product location is unknown.The investigation is in process.Upon completion of the investigation or receipt of additional information, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial knee arthroplasty.Approximately two years post implantation, the patient underwent revision surgery due to pain and patellar maltracking.It was noted that the femoral rotation of the implant was a contributing factor to the event.Due diligence is in process for this event; at the time of this report no further information has been made available.
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.H6: proposed component (annex g) code is mechanical (g04) - femur.Visual and dimensional evaluations of the product 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.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
It was reported that a patient underwent an initial total knee arthroplasty.Approximately two years post implantation, the patient underwent revision surgery due to anterior knee pain and patellar maltracking.During revision surgery, the surgeon noted femoral rotation and noted that it was a contributing factor to the patella maltracking.A patellar component was implanted and the articular surface was exchanged without complication.The femoral and tibial components remain implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D6b: the device remains implanted.D10: medical product: articular surface medial congruent (mc) right 10 mm height: catalog#: 42522101010, lot#: 64556895; tibia cemented 5 degree stemmed right size h: catalog#: 42532008302, lot#: 64355766.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS
• 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: 15092556
• Report Number: 0001822565-2022-02149
• Device Sequence Number: 5048468
• Product Code: MBH
• UDI-Device Identifier: 00889024230866
• UDI-Public: (01)00889024230866(17)291231(10)64592525
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 08/31/2022
• 2 Devices were Involved in the Event: 1 2

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: 42-5028-074-02
• Device Catalogue Number: 42502807402
• Device Lot Number: 64592525
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 07/26/2022; 08/30/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/16/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 128 KG