MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) LEFT 14 MM; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Muscle Weakness/Atrophy (1967); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Bursitis (4832); Joint effusion (4849)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
Revision - (b)(4) persona revision knee post market us.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 a study patient developed mild tenderness of the pes aneserinus about one year post implantation and was prescribed topical voltaren cream.The patient continued through the study without complication until experiencing an unknown twisting injury approximately two years later.Patient complained of medial knee pain and popping and was diagnosed with pes bursitis and hamstring tendinitis with a prescription for physical therapy, steroids, and topical diclofenac gel.The pain continued to worsen into the anterior knee and began to experience limited range of motion and difficulty ambulating, swelling, stiffness, and hamstring/quad weakness.A prescription for lyrica and a knee brace were prescribed one month from the previous visit, patient had elevated wbc and a positive synovasure result from an aspiration.The cultures remained negative and the patient underwent an i&d with poly exchange one month later.No additional information has been provided.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.The reported products were reviewed for compatibility with no issues noted.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: 1st visit clinic notes: knee swelling, pain- states started after last therapy session on thursday and was doing well until that point and then the next day, had limited motion and difficulty walking; 2nd visit: left knee poly exchange: periprosthetic joint infection, poly liner was explanted, remaining components found to be well aligned and stable complaint is confirmed with provided medical records.The root cause for infection is determined to be unrelated to implanted zimmer biomet device.A definitive root cause cannot be determined for the pain, stiffness, swelling.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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.

• Brand Name: ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) LEFT 14 MM
• 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: 18574050
• Report Number: 0001822565-2024-00240
• Device Sequence Number: 12743266
• Product Code: JWH
• UDI-Device Identifier: 00889024554511
• UDI-Public: (01)00889024554511(17)240131(10)64264925
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 03/05/2024

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 Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42512800914
• Device Lot Number: 64264925
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 01/24/2024; 03/04/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/16/2024; 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American