MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED LEFT SIZE C STEM EXTENSION USE REQUIRED; PROSTHESIS, KNEE

Model Number	42-5420-064-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that six months post the revision knee arthroplasty surgery the patient had pain, bursitis, tendonitis and it band syndrome.The patient was injected with medication and instructed to use anti-inflammatory cream and a compression sleeve.The products remain implanted and there are no plans for a second revision surgery at this time.
Additional Manufacturer Narrative
(b)(4).Medical product: articular surface fixed bearing constrained condylar knee (cck) left 14 mm height: catalog#:42512800414, lot#:64512550; femur cemented plus left size 5+: catalog#:42504605811, lot#:64636333; stem extension 3mm offset splined uncemented 11 mm diameter +135 mm length: catalog#:42560313511, lot#:64769814; stem extension 3mm offset splined uncemented 10 mm diameter +135 mm length: catalog#:42560313510, lot#:64804919; tibial augment cemented half block left lateral size cd 5 mm thickness: catalog#:42555803105, lot:64835156; tibial augment cemented half block left medial size cd 5 mm thickness: catalog#:42555803305, lot#64613203.Customer has indicated that 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
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 were 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: no complication during the procedure.Subsequently, the patient experienced pain, bursitis, tendonitis, and it band syndrome and was injected with medication, instructed to use anti-inflammatory cream and a compression sleeve.Root cause was unable to be determined.Pain is a known adverse effect of the system.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
Additional information provided does not alter previous investigation conclusions.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 a left revision knee arthroplasty.Approximately three months post implantation, the patient experienced an initial onset of pes anserinus bursitis of the left knee.At six months, the patient had pain, bursitis, tendonitis and it band syndrome.The patient was then injected with medication and instructed to use anti-inflammatory cream and a compression sleeve.The products remain implanted and there are no plans for a second revision surgery at this time.

• Brand Name: TIBIA FIXED CEMENTED LEFT SIZE C STEM EXTENSION USE REQUIRED
• 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: 12782588
• Report Number: 0001822565-2021-03253
• Device Sequence Number: 19734843
• Product Code: JWH
• UDI-Device Identifier: 00889024562776
• UDI-Public: (01)00889024562776(17)300812(10)64714221
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 03/31/2022

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: 42-5420-064-01
• Device Catalogue Number: 42542006401
• Device Lot Number: 64714221
• 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: 10/20/2021
• Supplement Date Received by Manufacturer: 02/14/2022; 03/21/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/17/2022; 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 69 KG