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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHETIC, HIP
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ZIMMER BIOMET, INC. FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; PROSTHETIC, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214)
Patient Problems Necrosis (1971); Pain (1994); Local Reaction (2035); Scar Tissue (2060); Metal Related Pathology (4530)
Event Date 01/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: item#00620205022 | item name shell porous with cluster holes 50 mm | lot# 62191132.Item#00631005032 | item name liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells | lot#62195676.Item#00625006530 | item name bone screw self-tapping 6.5 mm dia.30 mm length | lot#62194317.The device will not be returned for analysis as location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00500.
 
Event Description
It was reported the patient underwent a initial left tha.Patient was subsequently revised 7 years later due to elevated metal ion levels, altr, necrosis, pain, scar tissue, and in-vivo corrosion.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0002648920 - 2021 - 00134.
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 0002648920 - 2021 - 00134.
 
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Brand Name
FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
Type of Device
PROSTHETIC, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key11404847
MDR Text Key234450603
Report Number0001822565-2021-00501
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 05/25/2021
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 Expiration Date10/27/2022
Device Model NumberN/A
Device Catalogue Number00801803201
Device Lot Number62205389
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/12/2021
Initial Date FDA Received03/03/2021
Supplement Dates Manufacturer Received05/24/2021
Supplement Dates FDA Received05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight68
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