MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL COMPONENT SIZE D RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Unstable (1667)

Patient Problems Damage to Ligament(s) (1952); Limited Mobility Of The Implanted Joint (2671); Patient Problem/Medical Problem (2688)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products : articular surface 14 mm height.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 03224.

Event Description

It was reported that patient underwent right knee revision ten years ago.Subsequently, patient was revised again approximately 3 weeks later due to instability.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Primary operative notes (surgery date: (b)(6) , 2007) does not suggest any intra operative complications.Patient underwent a revision surgery on (b)(6) , 2010 for loose patella augment and abrading femoral component and poly liner exchange.Patient underwent second revision on (b)(6) , 2020 due to instability.Hemarthrosis & hemosiderin deposits were noted.Removed poly liner and found metallic deposits in posterior capsular.X-rays were provided however per review by nursing team images will not be submitted for hcp review as the second revision operative records discuss reason for revision, and images would not enhance investigation at this time.Root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: FEMORAL COMPONENT SIZE D RIGHT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10522396
• MDR Text Key: 206550457
• Report Number: 0001822565-2020-03225
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K060370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00576401452
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• 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: 57