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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Material Erosion (1214)
Patient Problems Necrosis (1971); Pain (1994); Swelling (2091); Tissue Damage (2104); Reaction (2414)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed due to limited information received from the customer. Review of the device history records identified no related deviations or anomalies during manufacturing. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04753.
 
Event Description
Patient¿s legal counsel reported that a patient underwent right total hip arthroplasty. Legal counsel further reports patient underwent a revision procedure approximately 4 years later due allegations of pain, swelling, metallosis, trunnionosis and altr. No further event information available at the time of this report.
 
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Brand NameFEMORAL HEAD STERILE PRODUCT
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9311018
MDR Text Key166312295
Report Number0002648920-2019-00811
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00801803602
Device Lot Number62813853
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/02/2014
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 Treatment Data
Date Received: 11/12/2019 Patient Sequence Number: 1
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