MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT; PROSTHESIS KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: zimmer unicompartmental femoral component, catalog # 00584201401, lot # 63408604; articular, catalog # 00584202308, lot # 63243594.Customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-01610.

Event Description

It was reported that the patient underwent a left partial knee arthroplasty.Subsequently, the patient is going to be considered for a total knee revision arthroplasty due to pain and loosening.No revision occurred to date, and implant remains in patient.Attempt for further information has been made, but no further information has been provided.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.The following sections have been updated: 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.- attachment: [maude report (b)(4).Pdf].

Event Description

It was further reported that the patient has severe pain while standing and walking.Patient also reports a limp while walking and alleges severe discomfort.

Manufacturer Narrative

Upon review of additional information received, it has been determined that zimmer biomet does not hold reporting responsibility for this product.Therefore, this event is not reportable.

Event Description

Upon review of additional information received, it has been determined that zimmer biomet does not hold reporting responsibility for this product.Therefore, this event is not reportable.

• Brand Name: ZIMMER UNICOMPARTMENTAL TIBIAL COMPONENT
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7349827
• MDR Text Key: 102787171
• Report Number: 0001822565-2018-01621
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• PMA/PMN Number: PK033363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• 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: 00584200301
• Device Lot Number: 63498817
• Other Device ID Number: (01) 00885556619896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90