MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL DISTAL AUGMENT CEMENTED SIZE 9, 9+ 10 MM THICKNESS; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00937, 0001822565-2022-00938, 0001822565-2022-00939, 0001822565-2022-00940, 0001822565-2022-00941, 0001822565-2022-00942, 0001822565-2022-00943, 0001822565-2022-00944, and 0001822565-2022-00946.Concomitant medical devices: femoral posterior augment cemented size 9, 9+ 5 mm thickness, catalog#: 42556806605, lot#: 64416182.Femoral posterior augment cemented size 9, 9+ 5 mm thickness, catalog#: 42556806605, lot#: 64459736.Femoral central cone size small, catalog#: 42545001011, lot#: 64500868.Tibia fixed cemented right size c, catalog#: 42542006402, lot#: ni.Tibial central cone size small, catalog#: 42545000511, lot#: 64627891.Femur cemented standard right size 9, catalog#: 42504606602, lot#: 64862199.Tibial augment cemented half block right medial size cd 15 mm thickness, catalog#: 42555803415, lot#: 64664300.Tibial augment cemented half block right lateral size cd 15 mm thickness, catalog#: 42555803215, lot#: 64664291.Stem extension straight splined uncemented 12 mm diameter +175 mm length, catalog#: 42560117512, lot#: 64653842.Palacos cement ,catalog#: 5036964, lot#: 94944865.Stem extension straight splined uncemented 14 mm diameter +135 mm length, catalog#: 42560113514, lot#: 64707053.Articular surface fixed bearing constrained condylar knee (cck) right 14 mm height, catalog#: 42522800514, lot#: 64372518.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately one year post-implantation, the patient reports persistent pain.Radiology results reveal increased radiolucency concerning for loosening of the tibia and a stable periprosthetic fracture at the lateral femoral condyle.Due to the bone loss from two prior revisions, the patient does not want to pursue another revision and will be treated conservatively at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a lateral femoral condyle fracture occurred, x-rays showed radiolucency, and radiographic evidence of loosening, and bone loss.Device history record was reviewed and no discrepancies relevant 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 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: FEMORAL DISTAL AUGMENT CEMENTED SIZE 9, 9+ 10 MM THICKNESS
• 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: 13977972
• Report Number: 0001822565-2022-00936
• Device Sequence Number: 5568177
• Product Code: JWH
• UDI-Device Identifier: 00889024556812
• UDI-Public: (01)00889024556812(17)290731(10)64475630
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 07/21/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42556606610
• Device Lot Number: 64475630
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2019
• 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.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 106 KG