MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VG CRL MONO-LCK BRG 12X71; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vg crl mono-lck brg; p/n: 189262, l/n: 659910; vanguard cr ilok fem-rt; p/n: 183010, l/n: j6419377.Customer has indicated that the product will not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00951.Remains implanted.

Event Description

It was reported patient underwent a manipulation under anesthesia (mua) approximately two months post-implantation due to moderate stiffness.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Review of the medical records indicated that the patient had underwent manipulation under anesthesia.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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: VG CRL MONO-LCK BRG 12X71
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8422303
• MDR Text Key: 138847322
• Report Number: 0001825034-2019-00950
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K060525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: N/A
• Device Catalogue Number: 189262
• Device Lot Number: 659910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 99