MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIA FIXED CEMENTED STEM EXTENSION; PROSTHESIS KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical product: femur cemented catalog # 42504605812 lot # 65604351; articular surface fixed bearing constrained condylar knee (cck) catalog # 42522800612 lot # 64615548; stem extension offset splined uncemented catalog # 42560613512 lot # 65645041; stem extension offset splined uncemented catalog # 42560613514 lot # 65703571; tibial augment cemented half block catalog # 42555805405 lot # 65085595; tibial augment cemented half block catalog # 42555805205 lot # 65102663.Mri sterile short osteotome blade 12mm catalog # 47996602122 lot # 56715440.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2023-01816; 0001822565-2023-01818; 0001822565-2023-01819; 0001822565-2023-01820; 0001822565-2023-01821; 0001822565-2023-01822.

Event Description

It was reported patient is experiencing ambulation difficulties, pain, swelling, redness in knee post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

Upon receipt of information received and reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

Event Description

It was reported patient is experiencing ambulation difficulties, pain, swelling, redness in knee post implantation.It was further reported that the patient's pain levels are out of control, and they cannot walk unassisted.There is a future arthroscopy planned.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.It was previously reported on mfr#: 0001822565-2023-01817-1 that this event was considered non-reportable on behalf of zimmer biomet.However, upon receipt of additional information, it has been determined that report#: 0001822565-2023-01817-1 was drafted and submitted erroneously.This event remains reportable as it has been indicated the patient has suffered a serious injury.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.This complaint has been confirmed by the presence of nickel.The additional information received does not change the previous investigation.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 Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified the patient as having swollen lower legs and ankles.No product was returned or pictures of the products provided.Review of the device history records identified no deviations or anomalies during manufacturing.Compatibility of the devices was reviewed with no issues noted.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified that the patient was experiencing pain, swelling, ambulation difficulties, and could not walk unassisted due to pain.A definitive root cause could not be determined.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 Description

No additional information to report.

• Brand Name: TIBIA FIXED CEMENTED STEM EXTENSION
• 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: 17269626
• MDR Text Key: 318497025
• Report Number: 0001822565-2023-01817
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/30/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42542007102
• Device Lot Number: 65503331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 06/29/2023; 08/01/2023; 11/01/2023; 11/27/2023
• Supplement Dates FDA Received: 07/25/2023; 08/10/2023; 11/10/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2022
• 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): Other
• Patient Sex: Female