MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT CR/PS/LPS SIZE 5; PROSTHESIS, KNEE

Catalog Number	00598604701
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an initial total knee arthroplasty.Approximately three years post-implantation, the patient presented with ongoing knee pain and difficulty walking due to a deep tissue infection.Subsequently, the patient underwent revision surgery where a loose tibial component was also revealed.Following revision surgery, the patient continued with ongoing antibiotic treatment for the infection.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).D10: medical product: femoral component option size f right compatible with lps-flex prolong: catalog#00596401652, lot#63784946; articular surface size ef 10 mm height: catalog#00596404010, lot#65307716.G2: foreign: united kingdom.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, 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 have been updated: b4; b5; g3; h2; h3; h6; h11.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.Root cause was unable to be determined.Reported event was unable to be confirmed.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
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d9; g3; h2; h3; h6; h11.Visual evaluation of the returned products found evidence of use (surgical debris and surface scratches); however, no further information can be determined for the tibial component.Device was measured in areas accessible with no bone cement residue and found to be conforming to manufacturing specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.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: NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT CR/PS/LPS SIZE 5
• 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: 19080222
• Report Number: 0001822565-2024-01205
• Device Sequence Number: 5859641
• Product Code: JWH
• UDI-Device Identifier: 00889024218857
• UDI-Public: (01)00889024218857(17)310330(10)J6994572
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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 Catalogue Number: 00598604701
• Device Lot Number: J6994572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 01/15/2025
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 09/19/2024; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Male