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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 12.5MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. TAPERLOC MICRO LAT FMRL 12.5MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091); Impaired Healing (2378)
Event Date 07/21/2009
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: biolox ceramic modular head ,catalog 12-115130, lot 179430; mallory head ringloc shell, 58mm catalog 11-104058, lot 947600; e-poly maxrom acetabular liner size 25, catalog ep-106885, lot 367240. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-07566, 0001825034-2018-07567, 0001825034-2018-07569, 0001825034-2018-07570.
 
Event Description
It was reported a patient underwent the first of a two-stage revision due to infection approximately four months post left total hip arthroplasty and then an i&d with placement of antibiotic beads four weeks later due to non-healing and drainage. Patient was re-implanted with permanent devices six weeks later during the stage ii procedure.
 
Manufacturer Narrative
Reported event was confirmed by review of op records provided. Op records of stage 1 revision stated that during procedure surgeon noted large subcutaneous fluid collection with purulence. Specimen was sent for culture/cell count, no results included. Fascia had dehisced and infection tracked through abductor repair & into joint space. Necrotic debris removed, stem and cup were noted well fixed and osteotomy was performed to remove stem. Op records of stage ii revision states that spacers were removed and permanent devices implanted. Device history record was reviewed and no discrepancies were found. Root cause was unable to be determined. 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.
 
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Brand NameTAPERLOC MICRO LAT FMRL 12.5MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7767401
MDR Text Key116555956
Report Number0001825034-2018-07566
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PK062994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Model NumberN/A
Device Catalogue Number15-103206
Device Lot Number481770
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/09/2018 Patient Sequence Number: 1
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