MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE EF 12 MM HEIGHT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a knee arthroplasty.Approximately 5 years post-op, the patient reports experiencing pain, swelling, implant shifting, and worn bone and is ambulating with crutches.The patient is scheduled for a revision.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D6a: implant date: (b)(6) 2019.D10: unknown - unknown nexgen tibial component - unknown.Unknown - unknown nexgen femoral component - unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.
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.D10: (b)(4) - stemmed nonaugmentable tibial component option cr/ps/lps size 4 for cemented use only - (b)(6).(b)(4) - femoral component option for cemented use only size f left - (b)(6).(b)(4) - all poly petella standard cemented size 35 mm diameter 9.0 mm thickness - (b)(6).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 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.Upon receiving additional information of the reported event, it was determined to be not reportable as the device did not cause or contribute to the reported event of tibial loosening.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.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE EF 12 MM HEIGHT
• 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: 20078392
• Report Number: 0001822565-2024-02768
• Device Sequence Number: 15369503
• Product Code: JWH
• UDI-Device Identifier: 00889024634930
• UDI-Public: (01)00889024634930(17)270731(10)64470462
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00596403212
• Device Lot Number: 64470462
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 08/27/2024; 09/18/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/04/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.; SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Prefer Not To Disclose