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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL STEM 12/14 NECK TAPER HIP PROSTHESIS

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ZIMMER, INC. FEMORAL STEM 12/14 NECK TAPER HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Swelling (2091); Weakness (2145)
Event Date 04/25/2016
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 00875705801 continuum tm cups 63265459. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required 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.
 
Manufacturer Narrative
(b)(4). Once the investigation has been completed, a follow up mdr will be submitted. (b)(4). Concomitant medical products - liner/ pn 00875101336/ ln 63279888, femoral head/ pn 00801803603/ ln 63290100, unknown cup/ pn and ln¿s unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-01817, 0001822565-2017-01819.
 
Event Description
It was reported that a patient had a total hip arthroplasty and is now experiencing pain and fluid buildup approximately one year post implantation.
 
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Brand NameFEMORAL STEM 12/14 NECK TAPER
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6501373
MDR Text Key249770855
Report Number0001822565-2017-01818
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK161830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00771101140
Device Lot Number63239906
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2016
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: 04/18/2017 Patient Sequence Number: 1
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