MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEM PRC LT M/RT L SML+; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-00442, 0001822565-2019-00443.Concomitant medical products: tib plate prc mlt/lrt s1 item# 00579004512 lot# 60091003, unknown mg uni-bearings item# 00588605810 lot# unknown.Customer has not indicated that 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 dr (b)(6) revised a patient's m/g uni to a left tka due to pain in the left knee.There is no additional information at this time.

Manufacturer Narrative

The complaint is considered confirmed as an image of the explanted device was provided.Bone cement was seen with the tibial and femoral components.Posterior end of the articular surface was discolored.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive 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: FEM PRC LT M/RT L SML+
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8310090
• MDR Text Key: 135154697
• Report Number: 0001822565-2019-00441
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: K942263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00579002200
• Device Lot Number: 60144637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention