MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT POROUS SIZE F LEFT; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problem Embolism (1829)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02289, 0002648920-2019-00388, 0001822565-2019-02290, and 0002648920-2019-00389.Concomitant medical products: stemmed nonaugmentable tibial component option cr/ps/lps size 7 catalog#: 00598605701 lot#: 63484719, articular surface regular constraint blue/c-h 10 mm height catalog#: 90597005010 lot#: 63560022, all poly patella size 35 mm dia.Standard 9.0 mm thickness catalog#: 00597206535 lot#: 63541871.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient underwent left total knee arthroplasty.Subsequently, the patient experienced a deep vein thrombosis that required hospitalization approximately one week post primary implantation.The issue was resolved and no further adverse events have reported.

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.Reported event was confirmed by review of operative notes.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: medial release, no intra-op complications, hospitalization required for two days observation pulmonary embolism and dvt.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.

• Brand Name: FEMORAL COMPONENT POROUS SIZE F LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8662565
• MDR Text Key: 146792975
• Report Number: 0001822565-2019-02289
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K031061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• 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: 00595201601
• Device Lot Number: 63608448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 83