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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED LEFT SIZE 9 PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PERSONA FEMUR CEMENTED LEFT SIZE 9 PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Use of Device Problem (1670)
Patient Problem Tissue Damage (2104)
Event Date 10/11/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Udi # (b)(4). Concomitant medical products: item # 42512000410 lot # 63996858, item # 42532006701 lot # 64355356. Report source: foreign (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00309, 3007963827-2019-00311. Customer has indicated that the product will not be returned to zimmer biomet for investigation as they product has been 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 a patient underwent a right tkr. The implants were checked by the surgeon prior to opening. However, the incorrect, left knee implants were opened in error. The incorrect, left implants were implanted and cemented before the surgeon realized the wrong implants were implanted. At this point, the bone cement had cured. The implants were removed with some bone loss occurring during the removal process. Once the incorrect implants were removed, the correct right side implants were implanted. Due to this malfunction, the patient had to undergo and additional surgery the next day to implant femoral and tibia stems. No additional patient consequences were reported. Attempts have been made and no further information has been provided.

 
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Brand NamePERSONA FEMUR CEMENTED LEFT SIZE 9
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 Key9271246
MDR Text Key164802288
Report Number3007963827-2019-00310
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK172524
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42502006601
Device LOT Number64431247
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 Received04/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/24/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/04/2019 Patient Sequence Number: 1
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