MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL FULL BLOCK AUGMENT PRECOAT SIZE 4 10 MM THICKNESS WITH 4 SCREWS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Swelling (2091); Ambulation or Postural Difficulties (2544); No Code Available (3191); Swelling/ Edema (4577)
Date of Event	12/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: item#: unknown; kne-nexgen-stemmed tibial component, size 4; lot#: unknown, item#: unknown; kne-nexgen-straight stem extension-unk; lot#:unknown, item#: 42540000035; all poly patella cemented 35 mm diameter; lot#: 63586415, item#: unknown; unknown nexgen tm distal femoral augment f, 10mm (medial); lot#: unknown, item#:unknown;unknown nexgen tm distal femoral augment f, 5mm (lateral); lot#:unknown, item#: unknown; unknown nexgen lcck femur f; lot#: unknown, item#: unknown; unknown nexgen lcck articular surface, 10mm; lot#: unknown, item#: unknown; unknown nexgen stemmed extension; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it is still implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01380.0001822565 - 2020 - 01377.
Event or Problem Description
The patient underwent a right total knee arthroplasty approximately 3 years ago.The patient was revised due to pain and tibial/femoral component loosening.After the revision the patient's symptoms improved until the one year follow up, which he reported increasing pain.Upon x-ray review, the surgeon noted the tibia appears to have subsided with some radiolucent lines present suggesting loosening.No revision has been scheduled at this time but is pending follow up in six months.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6 reported event was confirmed by review of medical records and x-rays.Device history record (dhr) review was unable to be performed as the part/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: initial ops notes were not provided.Revision surgery was performed on (b)(6) 2019 for pain, loose femur & tibial component.Also, the tibial component was subsided.All the components were revised during the surgery without complication.(b)(6) 2020, the patient was present with pain and moderate effusion of the knee.The x-ray review identified no change in the femoral component position.But, the tibia plate was slightly subsided on the lateral view.It also states : additionally, the tip of the stem is closer to the lateral cortex of the tibia than on the immediate postoperative xrays which likely means loosening and migration.The radiolucency line will be continued to monitor.The complaint is confirmed.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: medical product: stemmed tibial component precoat size 4 for cemented use only: catalog#00598003702, lot#64251672; stem extension straight 12mm dia x 100mm length(combined length 145mm): catalog#00598801012, lot#64158085; all poly patella cemented 35 mm diameter: catalog#42540000035, lot#63586415; trabecular metal distal femoral augment block: catalog#00549003620, lot#64149270; trabecular metal distal femoral augment block: catalog#00549003610, lot#63911523; femoral component option for cemented use only size f right: catalog#00599401692, lot#63549024; articular surface with locking screw size striped yellow/e f 10 mm height: catalog#00599403210, lot#63765056; stem extension straight 14mm dia x 100mm length(combined length 145mm): catalog#00598801014, lot#64238386; palacos rg 1x40 single: catalog#00111314001, lot#87974718.Upon receipt of additional information the previously associated report numbers were determined to be incorrectly filed.Please see the following associated reports pertaining to this event: 0002648920-2022-00077; 0002648920-2022-00078; 0001822565-2022-00945.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a revision right total knee arthroplasty.Approximately one year post implantation, the patient reported increasing pain.Upon x-ray review, the surgeon noted the tibia appears to have subsided with some radiolucent lines present suggesting loosening.The patient eventually underwent revision surgery one year and ten months post implantation due to aseptic loosening and subsidence of the tibial components.All components were revised.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Device history record was reviewed and no discrepancies were found.Review of complaint history found no additional related issues for this/these item(s) and the reported part and lot combination(s).No update to previously reported root cause.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: TIBIAL FULL BLOCK AUGMENT PRECOAT SIZE 4 10 MM THICKNESS WITH 4 SCREWS
• 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: 9962909
• Report Number: 0001822565-2020-01381
• Device Sequence Number: 16824010
• Product Code: JWH
• UDI-Device Identifier: 00889024220348
• UDI-Public: (01)00889024220348(17)280831(10)64129884
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2022

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: N/A
• Device Catalogue Number: 00598800410
• Device Lot Number: 64129884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 03/03/2022; 05/12/2022
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 04/24/2020; 04/01/2022; 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 106 KG