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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE E LEFT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. FEMORAL COMPONENT PRECOAT SIZE E LEFT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Swelling (2091); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)
Event Date 01/07/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00486. Concomitant medical devices: articular surface use with plate 3,4 size yellow/c-h 10 mm height, catalog#: 00595203010, lot#: 62066380; stemmed tibial component, catalog#: 00598003702, lot#: 62031439; stem extension replacement screw, catalog#: 00598009000, lot#: 62062312; taper stem plug, catalog#: 00596009900, lot#: 62036569; headed screw 48 mm length, catalog#: 00579104100, lot#: 62037223; headed screw 48 mm length, catalog#: 00579104100, lot#: 62037223; all poly patella size 32 mm dia. Standard 8. 5 mm thickness, catalog#: 00597206532, lot#: 62087178. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded. 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 left total knee arthroplasty. Subsequently, the patient was revised due to stiffness, pain, swelling, numbness, and audible noise.

 
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Brand NameFEMORAL COMPONENT PRECOAT SIZE E LEFT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer (Section G)
ZIMMER ORTHOPAEDIC MFG. LTD.
building no 2 east park
shannon industrial estate
shannon, county clare
EI
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8304800
MDR Text Key134994771
Report Number3007963827-2019-00033
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK071107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00575001501
Device LOT Number62042282
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 Received09/25/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2012
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: 02/05/2019 Patient Sequence Number: 1
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