MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN ROTATING HINGE FEMORAL STEM; PROSTHESIS, KNEE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Metal Related Pathology (4530)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, on an unknown time frame post-implantation, the patient underwent revision surgery due to detachment of the femoral component and femoral stem.Extensive metallosis was found in the joint during the procedure.Due diligence is in progress for this event; to date no further information has been reported.

Manufacturer Narrative

(b)(4).D10: unknown nexgen rotating hinge femoral component: catalog#ni, lot#ni; unknown tibial tray: catalog#ni, lot#ni; unknown articular surface: catalog#ni, lot#ni.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated report: 0001822565-2024-00374.Diligence is in process to determine whether the product is available for evaluation.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.H3 other text : see h10 narrative.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The followings sections have been updated: b4; b5; g3; h2; h10.Upon receipt of additional information, it was determined that this device was reported to the incorrect mfr number.A corrected report has been filed under 0002648920-2024-00096.

Event Description

Upon receipt of additional information, it was determined that this device was reported to the incorrect mfr number.A corrected report has been filed under 0002648920-2024-00096.

• Brand Name: UNKNOWN NEXGEN ROTATING HINGE FEMORAL STEM
• Type of Device: 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: 18631017
• MDR Text Key: 334433679
• Report Number: 0001822565-2024-00375
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• 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: 04/02/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 03/08/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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