MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN STEMMED TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 8; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint effusion (4849)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a right total knee arthroplasty.Subsequently, the patient has a pending revision due to loosening of the tibial component.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: all poly patella standard cemented size 38 mm diameter 9.5 mm thickness catalog#: 00597206538 lot#: 63639795 femoral component option size g right compatible with lps-flex prolong catalog#: 00596401752 lot#: 63477161 articular surface size gh 10 mm height catalog#: 00596405010 lot#: 62768175 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b2, b3, b4, b5, b7, d6b, d10, g3, g6, h2, h6, and h11.D10 medical devices: all poly patella standard cemented size 38 mm diameter 9.5 mm thickness catalog#: 00597206538 lot#: 63639795.Femoral component option size g right compatible with lps-flex prolong catalog#: 00596401752 lot#: 63477161.Articular surface size gh 10 mm height catalog#: 00596405010 lot#: 62768175.Refobacin bc r 1x40 us catalog#: 110034355 lot#: 904bah3104.Refobacin bc r 1x40 us catalog#: 110034355 lot#: 904bah3104.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its 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
It was reported that patient underwent a right knee revision approximately four years post-implantation due to pain, loosening, and tibia subsidence.All components were removed except the patella.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Updated: b4, g3, g6, h2, h3, h6, and h11.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: findings: summary of pre-revision: increasing pain, limp, varus deformity, effusion/swelling, x-ray positive subsidence loosening, lucency.1 episode of buckling/locking of knee unstable, x-ray- loosening tibial.Negative infection works up.Revision op note: aseptic loosening tibial component.Tibial component frank loosening noted.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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: NEXGEN STEMMED TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 8
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19548287
• Report Number: 0002648920-2024-00191
• Device Sequence Number: 4850834
• Product Code: JWH
• UDI-Device Identifier: 00889024218888
• UDI-Public: (01)00889024218888(17)280630(10)64085509
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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): 11/26/2024

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: 00598605702
• Device Lot Number: 64085509
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 11/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/18/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2018
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Male
• Patient Weight: 138 KG