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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENT SHIELD HINGE SERVICE KIT SIZE F PROSTHESIS, KNEE

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ZIMMER BIOMET, INC. CEMENT SHIELD HINGE SERVICE KIT SIZE F 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); Necrosis (1971); Pain (1994); Hypovolemia (2243)
Event Date 11/14/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00069, 0001822565-2020-00071, 0001822565-2020-00072, 0001822565-2020-00075, 0002648920-2020-00017, 0001822565-2020-00076, 0001822565-2020-00080, and 0001822565-2020-00081. Medical devices: articular surface with segmental hinge post size f 26 mm height catalog#: 00585006026 lot#: 61036887, tibial component precoat size 3 catalog#: 00588000300 lot#: 62128962, femoral component option for cemented use only size f left catalog#: 00588001601 lot#: 60915244, tibial block and screws precoat size 4 10 mm thickness catalog#: 00598800427 lot#: 60836308, stem extension sharp fluted 15mm dia x 75mm length catalog#: 00598801515 lot#: 61798489, stem extension sharp fluted 22mm dia x 75mm length catalog#: 00598801522 lot#: 60437392, palacos rg 1x40 single catalog: 00111314001 lot: 74624301, palacos rg 1x40 single catalog: 00111314001 lot: 74624301, trabecular metal tibial half block augment tapered right lateral / left medial with screws catalog#: 00544800429 lot#: 61787914, trabecular metal femoral augment block distal only catalog#: 00549003624 lot#: 61825154. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that patient underwent a knee procedure. Subsequently, around five years later, the patient was revised due to pain and aseptic loosening. During the revision, heterotopic ossification and femoral necrosis were noted.
 
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Brand NameCEMENT SHIELD HINGE SERVICE KIT SIZE F
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 Key9559089
MDR Text Key174202263
Report Number0001822565-2020-00070
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberN/A
Device Catalogue Number00585007516
Device Lot Number62145974
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 Received04/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2012
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: 01/07/2020 Patient Sequence Number: 1
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