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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR NECK G2 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP

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ZIMMER BIOMET, INC. MODULAR NECK G2 12/14 NECK TAPER USE WITH +0 HEADS ONLY PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Sepsis (2067); Swelling (2091); Hypovolemia (2243); Reaction (2414); Blood Loss (2597); No Information (3190)
Event Date 03/12/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 00771300900 62309332 m/l taper kinectiv stem size 9, ep-108524 921590 e-poly 40mm +3 hiwall lnr sz24, 106054 884870 ran/bur rnglc shl 54mm sz 24, 00801804002 62358028 femoral head. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported by patients¿ legal counsel that the patient underwent a right hip revision procedure approximately 5 years post-implantation due to unknown reasons. It has also been noted that the devices have alleged to cause in vivo corrosion. Attempts were made to obtain additional information; however, none was available.
 
Manufacturer Narrative
(b)(4). If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends. An additional mdr report was filed for this event, please see associated report: 0001822565 - 2020 - 00961 stem, 0001825034 - 2020 - 01203 liner, 0001825034 - 2020 - 01204 shell.
 
Event Description
It was reported that the patient underwent a right hip revision procedure approximately 5 years post-implantation due metallosis, tissue damage, periprosthetic fracture and infection, polyethylene failure.
 
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Brand NameMODULAR NECK G2 12/14 NECK TAPER USE WITH +0 HEADS ONLY
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9577386
MDR Text Key174662579
Report Number0001822565-2020-00152
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
K063251
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00784803201
Device Lot Number62198159
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/10/2020 Patient Sequence Number: 1
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