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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN STEM HIP PROSTHESIS

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ZIMMER, INC. UNKNOWN STEM HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
Current information is insufficient to permit a conclusion to the cause of the event. Lee, soong joon et al (2016). "bearing change to metal-on-polyethylene for ceramic bearing fracture in total hip arthroplasty; does it work?" the journal of arthroplasty, 31, 204-208. Http://dx. Doi. Org/10. 1016/j. Arth. 2015. 08. 039.
 
Event Description
A patient identified in the article underwent hip revision due to metallosis and elevated metal ion levels. There has been no further information provided and the patient outcome is unknown.
 
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Brand NameUNKNOWN STEM
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6420496
MDR Text Key70433574
Report Number0001822565-2017-01821
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/21/2017 Patient Sequence Number: 1
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