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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIAL PROSTHESIS, KNEE

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ZIMMER ORTHOPAEDIC MFG. LTD. PARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIAL PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Positioning Failure (1158); Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001825034-2019-04750. Concomitant medical products partial articular surface right medial, item# 42528200409, lot# 63887348. Report source - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that, during a unicompartmental knee arthroplasty procedure, an articular surface would not seat to the tibial tray. The surgeon removed the articular surface and tried to insert it multiple times. Although the articular surfaces seemed to mate with the tibial tray, there was concern that the surface was damaged and a backup articular surface was used to complete the procedure. There is no additional information at this time.

 
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Brand NamePARTIAL TIBIAL CEMENTED SIZE D RIGHT MEDIAL
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 Key9217742
MDR Text Key167208679
Report Number3007963827-2019-00301
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK161592
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 02/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42538000402
Device LOT Number64318523
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 Received02/10/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/22/2019
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

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