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

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.

• Brand Name: UNKNOWN PALACOS CEMENT
• Type of Device: BONE 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 Key: 6999480
• MDR Text Key: 91070905
• Report Number: 0001822565-2017-07650
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• 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 Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR