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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 71MM PROSTHESIS KNEE

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ZIMMER BIOMET, INC. BIOMET ILOK PRI TIB TRAY 71MM PROSTHESIS KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical products: vngd ti fem cr 62. 5mm rt catalog # cp113616 lot # 176190, vngd ant stab brg 13x71 catalog # 189063 lot # 919050, series a pat std 31 3 peg catalog # 184764 lot # 950430. Customer has indicated that the product will not be returned because it remains implanted. Multiple mdr reports were filled for this event: 0001825034-2021-02136, 0001825034-2021-02139, 0001825034-2021-02140. 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
It was reported that the patient underwent a knee arthroplasty. Subsequently, the patient had a manipulation under anesthesia due to pain, stiffness and arthrofibrosis. No revision procedure has been reported to date. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameBIOMET ILOK PRI TIB TRAY 71MM
Type of DevicePROSTHESIS KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12216712
MDR Text Key263093991
Report Number0001825034-2021-02138
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number141213
Device Lot Number012440
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/23/2021 Patient Sequence Number: 1
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