MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN LONG 14MM DIAMETER 155MM LENGTH STRAIGHT STEM EXTENSION; PROSTHESIS, KNEE

Catalog Number 00598801114

Device Problems Material Erosion (1214); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Pain (1994); Joint Laxity (4526); Metal Related Pathology (4530)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: medical product: unknown nexgen femoral component size f: catalog#ni, lot#ni; size 6 precoat cemented tibial component: catalog#00588000600, lot#62026494; 12mm diameter 100mm length straight stem extension combined length 145mm: catalog#00598801012, lot#62066296; 14mm height size f articular surface with hinge post extension: catalog#00588006014, lot#62413009; unknown 35mm patella component: catalog#ni, lot#ni; unknown tm cone 10mm: catalog#ni, lot#ni; unknown tm cone 5mm: catalog#ni, lot#ni; unknown refobacin cement: catalog#ni, lot#ni; unknown palacos cement: catalog#ni, lot#ni.G2: foreign: germany.The product is not available for evaluation as the patient has not consented for return to the manufacturer.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a left total knee arthroplasty.Approximately eleven (11) years and six (6) months post-implantation, the patient presented with pain and instability in the knee.Subsequently the patient underwent revision surgery where the femoral stem was found to have detached from the femoral component.Extensive metallosis was also found in the joint during the procedure.All components were replaced without reported complication.Due diligence is complete as multiple attempts have been made however all available information has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - stem.Visual examination of the provided photographs identified an explanted tibial, femoral, stems, hinge post, articular surface and patella.There is no notable damage of the hinge post, step, or inner diameter of the femoral.There is some wear of the femoral poly box insert.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: dislocation at the connection between the femoral shaft cone and the femoral component, massive metallosis.Root cause was unable to be determined.Reported event was confirmed by review of provided medical records.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 Description

No further event information at time of this report.

• Brand Name: NEXGEN LONG 14MM DIAMETER 155MM LENGTH STRAIGHT STEM EXTENSION
• Type of Device: 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: 19031369
• MDR Text Key: 339225824
• Report Number: 0002648920-2024-00096
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K933785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 00598801114
• Device Lot Number: 61214729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 08/22/2024
• Supplement Dates FDA Received: 08/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 100 KG