MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SERIES A PAT STD 31 3 PEG; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number: (b)(4).Concomitant medical products: vanguard posterior stabilized tibial bearing, catalog #: ep-183660, lot #: 915390, biomet cruciate tibial tray, catalog #: 141235, lot #: j3687182, arcom series-a standard patella, catalog #: 184764, lot #: 494670, unknown palacos bone cement, catalog #: unknown, lot #: unknown.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of returned tibial tray and femur identified little to no cement fixation on the posterior side of the implants.The patellar component also shows no signs of cement fixation and one of the pegs appears to have been cut off.The peg was likely cut off during explanation.The tibial bearing has some small nicks and gouges on the superior surface.Dhr was reviewed and no discrepancies were found.A definitive root cause of the loosening cannot 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 09935, 0001825034 - 2018 - 02353 - 3, 0001825034 - 2018 - 02354 - 3.

Event Description

It was reported that the patient was revised to address component loosening and pain.Attempts have been made and no further information has been provided.

• Brand Name: SERIES A PAT STD 31 3 PEG
• 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: 8023920
• MDR Text Key: 125646579
• Report Number: 0001825034-2018-09935
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: N/A
• Device Catalogue Number: 184764
• Device Lot Number: 494670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• 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