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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 09/05/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Unique identifier (udi) #: n/a. Concomitant medical products: 42532007101, natural tibia, lot # 63895745; 42540000029, all poly patella, lot # 63890774; 42502606401, femur, lot # 63590448; 00590103533, 3. 5 mm hex head screw, lot # 63963443; 42509902525, 2. 5 mm hex screw, lot # 64038534, quantity x2. Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00279, 0002648920-2019-00714, 3007963827-2019-00279, 0001822565-2019-04191, 0001822565-2019-04192, 0001822565-2019-04193.

 
Event Description

It was reported that approximately 1 year post implantation, the patient has been experiencing pain, loss of mobility, and device loosening. Attempts have been made and no further information has been provided.

 
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Brand NameARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 10 MM HEIGHT
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 Key9128856
MDR Text Key160350126
Report Number3007963827-2019-00278
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42512200510
Device LOT Number63880311
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/10/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/27/2019 Patient Sequence Number: 1
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