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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL AUGMENT BLOCK DISTAL ONLY PRECOAT PROSTHESIS KNEE

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ZIMMER BIOMET, INC. FEMORAL AUGMENT BLOCK DISTAL ONLY PRECOAT 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); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
It was reported patient is experiencing pain over the pes anserine bursa, swelling, stiffness and decrease in flexion two years post implantation. Labs and a bone scan were ordered, but no further information or report of intervention has been provided at this time. Attempts to obtain additional information have been made; however, no more is available at this time.
 
Manufacturer Narrative
(b)(4). Medical products: lcck nexgen articular surface with locking screw catalog #: 00599403212, lot #: 62749599. Nexgen stems extension sharp fluted catalog #: 00598801514 ,lot #: 63203982. Nexgen stems catalog #: 00598801117, lot #: 63215489. Nexgen stemmed tibial component catalog #: 00598800400, lot #: 63402724. Lcck nexgen femoral component catalog # 00599401591, lot #: 63592705. Femoral augment block distal only precoat catalog #: 00599003524, lot #: 77003571. Lcck nexgen articular surface with locking screw catalog #: 00599403217, lot #: 63864189. 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: 0001822565-2022-00381 0002648920-2022-00030 0002648920-2022-00031 0001822565-2022-00390 0001822565-2022-00394 two device ids were provided by the reporter; of these, only one (1) was reported for pain, swelling, stiffness and decrease in flexion. It is unknown which exact device encountered this issue, it is one of the following: femoral augment block distal only precoat catalog #: 00599003523, lot #: 61668091. Manufacture date: nov 29, 2010 sterile expiry date: nov 30, 2020 510k: k152494 pro code: kro or femoral augment block distal only precoat catalog #: 00599003524, lot # :77003571. Manufacture date: may 8, 2014 sterile expiry date: apr 30, 2024 udi: (01)00889024563896(17)240430(10)77003571 510k: k152494 pro code: kro remains implanted.
 
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Brand NameFEMORAL AUGMENT BLOCK DISTAL ONLY PRECOAT
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 Key13497928
MDR Text Key285457713
Report Number0001822565-2022-00395
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2020
Device Model NumberN/A
Device Catalogue Number00599003523
Device Lot Number61668091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2010
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: 02/09/2022 Patient Sequence Number: 1
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