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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC POR FMRL STEM 5.0X130; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC POR FMRL STEM 5.0X130; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Swelling (2091); Tissue Damage (2104); Reaction (2414); Ambulation Difficulties (2544)
Event Date 09/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: mri positive and cobalt chromium both elevated cobalt level 139.2 & chromium level 133.8 tissue stained dark grey, and avascular was noted to some of the tissue revision records: surgeon notes large osteolysis, and soft tissue damage as well as acetabular fractures prior to revision.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08590.0001825034 - 2020 - 03672.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 patient underwent total hip arthroplasty approximately 14 years ago.Patient underwent revision 10 years post implantation due to patient complaint of metallosis, tissue death, bone damage, lack of mobility, inflammation, metal poisoning.No further event information available at the time of this report.
 
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Brand Name
TAPERLOC POR FMRL STEM 5.0X130
Type of Device
PROSTHESIS, HIP
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 Key10613801
MDR Text Key209418888
Report Number0001825034-2020-03673
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/01/2020
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 Date02/28/2016
Device Model NumberN/A
Device Catalogue Number103200
Device Lot Number697660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2006
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 Sequence Number1
Treatment
BIOMET M2A TPR INSRT CAT#139252 LOT#186580
Patient Outcome(s) Hospitalization; Required Intervention;
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