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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PALACOS CEMENT BONE CEMENT, ANTIBIOTIC

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ZIMMER BIOMET, INC. UNKNOWN PALACOS CEMENT BONE CEMENT, ANTIBIOTIC Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 08/22/2017
Event Type  Injury  
Manufacturer Narrative

Zimmer biomet complaint number (b)(4). Medical product- psn fem cr por ccr std sz8 l, catalog #: 42502806401, lot #: 62763696. Psn asf uc 16mm ply l 4-11 ef, catalog #: 42511200516, lot#: 62715755. Psn all poly pat ply 32mm, catalog #: 42540000032, lot #: 62816540, and tibia cemented 5 degree stemmed left size f catalog #: 42532007501, lot #: 631121162. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2017-00667. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Review of the complaint history determined that no further action is required as no were trends identified. 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. Product location unknown.

 
Event Description

It was reported the patient underwent a left total knee arthroplasty. Subsequently, it was reported the patient underwent a revision procedure approximately twenty months post-implantation due to possible loosening and pain. Attempts have been made and no further information has been provided.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was confirmed based on operative records received indicating that the patient was suffering from left knee pain due to tibial base plate loosening after bone scan and radiographic evaluation. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

 
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Brand NameUNKNOWN PALACOS CEMENT
Type of DeviceBONE CEMENT, ANTIBIOTIC
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 Key6999480
MDR Text Key91070905
Report Number0001822565-2017-07650
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
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 Received11/03/2017
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: 11/03/2017 Patient Sequence Number: 1
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