MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE CEMENT DOUGHTYPE RADIOPAQUE 40 G POLYMER POWDER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02199, 0001822565-2018-02206, 0002648920-2018-00304, 0001822565-2018-02217, 0002648920-2018-00303 concomitant medical products: articular surface size cd 10 mm height "use with plate 1, cat: 00596402210, lot: 63255305; all poly patella size 29 mm dia.Standard 8.0 mm thickness, cat: 00597206529, lot: 63239960; femoral component option for cemented use only size d left, cat: 00599601451, lot: 62946321; tibial component stemmed precoat, cat: 00598002702 lot: 63215865; bone cement dough type radiopaque 40 g polymer powder, cat: 00110201200, lot: 62786332.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient underwent left total knee arthroplasty on an unknown date.Subsequently, patient was revised due to tibial loosening, misalignment, pain and lack of range of motion.All components were removed and replaced.Additional information on the reported event is unavailable.

• Brand Name: BONE CEMENT DOUGHTYPE RADIOPAQUE 40 G POLYMER POWDER
• Type of Device: PROSTHESIS, KNEE
• 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: 7436987
• MDR Text Key: 105697669
• Report Number: 0001822565-2018-02216
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN17755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2017
• Device Model Number: N/A
• Device Catalogue Number: 00110201200
• Device Lot Number: 62786332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention