MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Pneumonia (2011)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign - new zealand.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2022-00326, 0002648920-2022-00254.

Event Description

It was reported that the patient underwent a right total knee arthroplasty.The same day, the patient was diagnosed with bilateral lower lobe pneumonia through chest x-ray.The patient was placed on augmentin for 7 days.The pneumonia resolved 3 weeks later without further complication.Attempts have been made and no further information has been provided.

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.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbidities, and perioperative management.Pneumonia is a well-known postoperative complication that typically requires medical intervention and possibly even hospitalization for more aggressive medical management.Within a two-hour postoperative window, the protective reflexes of the oropharyngeal passages are depressed, and the patient can aspirate.The reason for postoperative pneumonia is typically due to aspiration of subglottic secretions containing bacteria.Once the bacteria enter the respiratory tract, they can replicate and advance into aspiration pneumonia.Patient that have known history of respiratory or lung diseases such as copd, asthma, or are immune suppressed are at increased risk for developing this complication.Pneumonia is a procedural related complication resulting from intubation during the procedure and is considered a hospital-acquired condition.As the complaint indicates, a postoperative complication of pneumonia developed, and medical intervention was required for treatment.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.

• Brand Name: NATURAL TIBIA CEMENTED 5 DEGREE STEMMED LEFT SIZE E
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer (Section G): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15990533
• MDR Text Key: 305551527
• Report Number: 3007963827-2022-00327
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024471054
• UDI-Public: (01)00889024471054(17)261130(10)63490896
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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: 42532007101
• Device Lot Number: 63490896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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
• Patient Weight: 123 KG