MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE H 8 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Swelling (2091)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2019-00216, 3007963827-2019-00217.Concomitant medical products: partial femur cemented item# 42558000601 lot# 63944794, partial tibial cemented item# 42538000801 lot# 64032073.Customer has not indicated whether the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient was revised approximately two and a half months post implantation due to deep infection.There is no additional information at this time.

Event Description

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

Manufacturer Narrative

The reported event was confirmed through medical records.Primary surgery notes indicate no intra-operative complications.Three months¿ status post left medial uni-knee.X-rays report reveals well-positioned implants and no change from the six-week follow-up visit.Revision notes state that turbid fluid was seen that did communicate through a defect in the medial retinaculum of the knee joint.Implants were well fixed.All necrotic tissue was debrided and very little bone loss with the removal of the components.No devices were received; therefore the condition of the components is unknown.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.Root cause cannot 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.

Manufacturer Narrative

This follow-up is being submitted to update the complaint description and patient codes.Updated: date of report, event, pma/510k, type of reportable event, if follow-up, what type.

Event Description

It was reported that a patient was revised approximately two and a half months¿ post implantation due to pain, swelling, necrosis, and deep infection of the left knee.

• Brand Name: PARTIAL ARTICULAR SURFACE LEFT MEDIAL SIZE H 8 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8861275
• MDR Text Key: 153278980
• Report Number: 0001822565-2019-03230
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42518200808
• Device Lot Number: 64090439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 109