MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD CRUC RET TIB BRG 13X63/67; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Loss of Range of Motion (2032); Scar Tissue (2060)

Event Date 05/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.Once the investigation has been completed, a follow-up mdr will be submitted.Reference report: 0001825034-2021-01858.Investigation incomplete.

Event Description

It was reported that an initial right total knee arthroplasty was performed early 2021.Subsequently, the patient had a manipulation under anesthesia a month later due to arthrofibrosis.Attempts have been made, but no further information is available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.D10: medical product: vanguard cr ilok fem-rt 60, item#: 183004, lot#: j6952229.Biomet cc i-beam tray 67mm, item#: 141222, lot#: j6949402.Series a pat std 31 3 peg, item#: 184764, lot#: 950440.According to tabers medical dictionary, manipulation of a joint is a mobilization technique, sometimes involving a rapid thrust or stretching of a joint, with or without anesthesia.With anesthesia is (mua).Per clinical orthropaedics and related research (how to treat the stiff total knee arthroplasty? a systematic review), mua is used to treat and resolve arthrofibrosis (scar tissue).This procedure is performed to increase articular motion and reduce chronic pain from arthrofibrosis.The indication for manipulation under anesthesia is related to limited range of motion and stiffness due to adhesions/scar tissue.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: VANGUARD CRUC RET TIB BRG 13X63/67
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 12040443
• MDR Text Key: 257439971
• Report Number: 0001825034-2021-01842
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 0088030488055
• UDI-Public: (01)0088030488055(17)230305(10)120010
• Combination Product (y/n): N
• PMA/PMN Number: K171054
• 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: 07/22/2021

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: 03/05/2023
• Device Model Number: N/A
• Device Catalogue Number: 183423
• Device Lot Number: 120010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Other
• Patient Weight: 78