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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, C/4, TAPER 12/14 ZIMMER POROLOCK MIS STEM

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ZIMMER SWITZERLAND MANUFACTURING GMBH FITMORE, HIP STEM, UNCEMENTED, C/4, TAPER 12/14 ZIMMER POROLOCK MIS STEM Back to Search Results
Model Number N/A
Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)
Patient Problems Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Medical products: femoral head sterile product do not resterilize 12/14 taper; catalog#: 00-8018-036-04; lot#: 62806789. Liner elevated rim 36 mm i. D. Size ll for use with 58 mm o. D. Size ll shell; catalog#: 00-8752-013-36; lot#: 62969947. Shell with cluster holes porous 58 mm o. D. Size ll for use with ll liners; catalog#: 00-8757-058-01; lot#: 62939377. Bone screw self-tapping 6. 5 mm dia. 35 mm length; catalog#: 00-6250-065-35; lot#: 62955422. Therapy date: unknown. The manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
Patient was implanted on the left side and was monitored for cobalt levels. The result of cobalt level tests carried on different dates were high. The patient also has concerns towards fluid, culture and cell count to be done. The patient underwent multiple mri that detected the possible occurrence of pseudotumor. No mechanical issues have been detected with the implant. A revision surgery has not taken place yet.
 
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Brand NameFITMORE, HIP STEM, UNCEMENTED, C/4, TAPER 12/14
Type of DeviceZIMMER POROLOCK MIS STEM
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12116269
MDR Text Key262469024
Report Number0009613350-2021-00329
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberN/A
Device Catalogue Number01.00551.404
Device Lot Number2535526
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 Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2010
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: 07/05/2021 Patient Sequence Number: 1
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