MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PSN TIB STM 5 DEG SZ G L; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00102, 3007963827-2019-00103, 3007963827-2019-00104, and 0002648920-2019-00269.Concomitant medical devices: psn fem ps cmt ccr std sz 10 l catalog#: 42500606801 lot#: 63983030, psn asf ps 11mm ve l 10-12 gh catalog#: 42512401011 lot#: 64065570, psn all poly pat ply 35mm catalog#: 42540000035 lot#: 64291028.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.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 left total knee arthroplasty.Subsequently, the patient experienced a pulmonary embolism eleven days after the procedure, which required hospitalization.No revision procedure has been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient is obese with a bmi 34.2, no intra-op complications noted, aspirin prescribed, compression stockings utilized for dvt prophylaxis, hospitalized for pulmonary embolism experienced within 2 weeks post-operation and discharged in 2 days.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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 further event information available at the time of this report.

• Brand Name: PSN TIB STM 5 DEG SZ G L
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC MFG. LTD.; building no 2 east park; shannon industrial estate; shannon, county clare ; EI
• MDR Report Key: 8515163
• MDR Text Key: 141965407
• Report Number: 3007963827-2019-00103
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• 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: 42532007901
• Device Lot Number: 64075190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 111