MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL FEMUR CEMENTED SIZE 6 LEFT MEDIAL; 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: 3007963827-2019-00217, 0001822565-2019-03230.Concomitant medical products: partial tibial cemented, item # 42538000801, lot # 64032073.Partial articular surface left medial, item # 42518200808, lot # 64090439.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.

Manufacturer Narrative

This follow-up is being submitted to update the complaint description and patient codes.

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.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Updated: b4, b5, g4, g7, h1, h2, h3, h6, and h10.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.

Event Description

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

• Brand Name: PARTIAL FEMUR CEMENTED SIZE 6 LEFT MEDIAL
• 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: 8861269
• MDR Text Key: 153278350
• Report Number: 3007963827-2019-00216
• 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 Model Number: N/A
• Device Catalogue Number: 42558000601
• Device Lot Number: 63944794
• 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