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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Reaction (2414)
Event Date 09/07/2017
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 location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Additional concomitant medical products: 00801803202, femoral head, lot # 62332074; part # unk, cup, lot # unk; part # unk, liner, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2018 - 00887.
 
Event Description
It was reported that approximately 4 years post implantation, the patient underwent a revision due to elevated chromium ion levels.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined this report is a duplicate of the event reported on 0001822565-2017-05772.The initial report was forwarded in error and should be voided.If additional information regarding this event is received, a supplemental report will be filed under 0001822565-2017-05772.
 
Event Description
Upon receipt of additional information, it has been determined this report is a duplicate of the event reported on 0001822565-2017-05772.The initial report was forwarded in error and should be voided.If additional information regarding this event is received, a supplemental report will be filed under 0001822565-2017-05772.
 
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Brand Name
FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8200513
MDR Text Key131531368
Report Number0001822565-2018-07066
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K032726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00771100740
Device Lot Number62400760
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2018
Initial Date FDA Received12/27/2018
Supplement Dates Manufacturer Received03/28/2019
Supplement Dates FDA Received03/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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