MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL DISTAL AUGMENT CEMENTED SIZE 7, 7+ 5 MM THICKNESS; PROSTHESIS, KNEE

Model Number	42-5566-062-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: articular surface fixed bearing constrained posterior stabilized (cps) left 16 mm height use with tibia sizes e-f / ps femur sizes 6-9: catalog#42512600716, lot#64536583; femur cemented plus left size 7+: catalog#42504606211, lot#64429274; stem extension 3mm offset splined uncemented 13 mm diameter +135 mm length: catalog#42560313513, lot#64559288; tibia fixed cemented left size f stem extension use required: catalog#42542007501, lot#64207423; tibial central cone size small: catalog#42545000511, lot#64189640; tibial augment cemented half block left medial size ef 15 mm thickness: catalog#42555805315, lot#64363791; tibial augment cemented half block left lateral size ef 10 mm thickness: catalog#42555805110, lot#64289805; stem extension 3mm offset splined uncemented 14 mm diameter +135 mm length: catalog#42560313514, lot#64514946; femoral distal augment cemented size 7, 7+ 10 mm thickness: catalog#42556606210, lot#64336285; refobacin bc r 1x40 us: catalog#110034355, lot#828ead1611, qty#3; refobacin bc r 1x40 us: catalog#110034355, lot#835aae2507.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-00445; 0001822565-2022-00446; 0001822565-2022-00447; 0001822565-2022-00448; 0001822565-2022-00449; 0001822565-2022-00450; 0001822565-2022-00451; 0001822565-2022-00452; 0001822565-2022-00454.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product 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 via a clinical study that a patient underwent a left revision procedure approximately two years post implantation due severe pain with twisting or stairs and moderate pain with patellar tendonitis.The patient was treated with a topical anti-inflammatory cream and the outcome was reported as resolved on the same day.The products remain implanted.Attempts to obtain additional information have been made; however, no more is available at this time.
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 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: that the patient fell and possibly injured the left knee, the x-ray shows well fixed implants, and patellar tendinitis was treated.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.

• Brand Name: FEMORAL DISTAL AUGMENT CEMENTED SIZE 7, 7+ 5 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: 13546113
• Report Number: 0001822565-2022-00453
• Device Sequence Number: 5200976
• Product Code: JWH
• UDI-Device Identifier: 00889024556737
• UDI-Public: (01)00889024556737(17)290131(10)64295436
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K181947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 42-5566-062-05
• Device Catalogue Number: 42556606205
• Device Lot Number: 64295436
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: White