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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HIP HIP PROSTHESIS

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ZIMMER BIOMET, INC. UNKNOWN HIP HIP PROSTHESIS Back to Search Results
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint- (b)(4). Reported event was unable to be confirmed as part number and lot number of the device involved in the incident is unknown. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. 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. This report is being submitted late as it has been identified in remediation. Frye, m. B. , berend, m. K. , morris, m. M. , adams, b. J. , & facs, a. L. (2013). Modular femoral tapered revision stems in total hip arthroplasty. Jisrf reconstructive review, 3(4), 32-37. Doi:10. 15438/rr. V3i4. 45.
 
Event Description
Information was received based on review of a journal article titled, "modular femoral tapered revision stems in total hip arthroplasty". This complaint identifies one (1) revision due to component breakage.
 
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Brand NameUNKNOWN HIP
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 Key6965073
MDR Text Key89832970
Report Number0001825034-2017-09012
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 10/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberN/A
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 Received06/15/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/20/2017 Patient Sequence Number: 1
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