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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET ARCOM PATELLA ALL POLY PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. BIOMET ARCOM PATELLA ALL POLY PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Muscular Rigidity (1968); Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical product: biomet cc cruciate tray 67mm catalog # 141232 lot # 582040; agc anatomic por fmrl 60 right catalog # 152732 lot # 437760; gen 4 cemvacpac 80 grsingle pk catalog # 402401 lot # 069440; universal z/hall styl 19. 7x100 catalog # 516065 lot # 88685; biomet arcom pat all poly 25mm catalog # cp102790 lot # 269420; agc trad pri tib bear 12x63/67 catalog # 151006 lot # 390650. Customer has indicated that the product will not be returned because it remains implanted. Multiple mdr reports were filled for this event: 0001825034-2020-03008, 0001822565-2020-02782. Heterotopic ossification is the abnormal and rapid growth of bone that forms within soft tissue as the result of heredity, trauma, or diseases of a joint. The rapid and irregular growth of bone often causes a sharp or jutted structure to form, causing pain and irritation to the surrounding tissues. The only treatment is surgical excision or shaving down to smooth out the excess bone. As time frames of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established. Please consider complaint category medical: heterotopic ossification. 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 an initial knee arthroplasty. Subsequently, the patient was revised due to heterotropic bone ossification, which contributed to the patient experiencing limited range of motion, pain, and stiffness. The surgeon removed excess bone and replaced the articular surface prosthesis. Attempt for further information has been made, but no further information has been provided.
 
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Brand NameBIOMET ARCOM PATELLA ALL POLY
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 Key10364803
MDR Text Key201714273
Report Number0001822565-2020-02818
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2009
Device Model NumberN/A
Device Catalogue NumberCP102790
Device Lot Number269420
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 Received07/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2004
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: 08/04/2020 Patient Sequence Number: 1
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