MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. NEXGEN 14MM DIAMETER 100MM LENGTH STRAIGHT STEM EXTENSION; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problems Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 03/02/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a right knee revision approximately eleven years post-implantation due to pain, metallosis, and disassociation of the femoral stem from the distal femoral implant.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2024-01000 and 0001822565-2024-01001.D10 medical devices: rotating hinge knee right size e cemented option femoral component, catalog#: 00588001502, lot#: 62080614.Tmt femoral diaphyseal cone, 30mm, medium, right, catalog#: 00545001831, lot#: 61972314.14mm height size e articular surface with hinge post extension, catalog#: 00588005014, lot#: 62366280.Unknown rhk tibial tray.Prc agmt block post sz e 10mm, catalog#: 00599003502, lot#: 61405568.Prc agmt block post sz e 10mm, catalog#: 00599003502, lot#: 62417507.Prc agmt block dist sz e 10mm, catalog#: 00599003520, lot#: 61529985.Prc agmt block dist sz e 10mm, catalog#: 00599003520, lot#: 61601937.G2 foreign source: australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent a right knee procedure.Subsequently, approximately eleven years later, the patient returned to surgery due to pain with the intention of exchanging the tibial insert.During the revision, metallosis and disassociation of the femoral stem from the distal femoral implant was noted.At the time of surgery, implants for a full revision were not available, so a new tibial insert was placed, the incision was closed, and the patient returned four days later for a revision of the femoral components.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: NEXGEN 14MM DIAMETER 100MM 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: 18958857
• MDR Text Key: 338352125
• Report Number: 0002648920-2024-00083
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K933785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: 04/05/2021
• Device Model Number: N/A
• Device Catalogue Number: 00598801014
• Device Lot Number: 61748147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 82 KG