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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET MAGNUM FEMORAL HEAD HIP PROSTHESIS

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ZIMMER BIOMET, INC. BIOMET MAGNUM FEMORAL HEAD HIP PROSTHESIS Back to Search Results
Catalog Number S001140
Device Problems Corroded; Material Erosion; Metal Shedding Debris; Naturally Worn
Event Date 09/23/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: item # 11-106056, shell, lot # 689230, item #, ep-108524, liner, lot # 640580, item #, 13-103200, stem, lot # 519370, item #, 31-32323o, drill bit, lot # 709050, item #, 103533, screw, lot # 815530, item #, 103532, screw, lot # 526530. Attorney. Reported event was confirmed by review of x-rays and medical records provided. Pre-revision radiograhps demonstrate a well fixed left total hip arthroplasty without lysis or asymmetric polyethylene wear. No evidence of loosening. There does appear to be some increased fluid collection and lateral to the greater trochanter and under the iliotibial band in the location of the trochanteric bursa. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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.

 
Event Description

It was reported that a patient underwent a left hip revision approximately 5 years post initial implantation, due to patient allegations of pain, metallosis, altr, elevated ion levels, necrosis, stiffness, pseudotumor and implant wear causing corrosion. Attempts have been made, and no further information is available.

 
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Brand NameBIOMET MAGNUM FEMORAL HEAD
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7402483
Report Number0001825034-2018-01637
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date02/28/2016
Device Catalogue NumberS001140
Device LOT Number628700
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 Received06/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/06/2018 Patient Sequence Number: 1
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