MAUDE Adverse Event Report: ZIMMER, INC. PERSONA POROUS 2 PEG TIBIAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

Persona femur ¿ catalogue # 42500006402; lot # 62764995.Persona articular surface ¿ catalogue # 42521400710; lot # 62846444.Persona patella ¿ catalogue # 42540000026; lot # 61631339.

Event Description

It is reported that the patient was experiencing pain and subsequently underwent revision due to aseptic loosening of the right knee.

Manufacturer Narrative

Complaint was evaluated and the reported event was confirmed.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The complaint components were reviewed for compatibility with no issues noted.Investigation results concluded that the reported event was due to a previously addressed design issue.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

During the revision procedure, surgeon confirmed loose tibial component with no bony ingrowth and the presence of a slimy layer consistent with fibrous ingrowth.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The articular surface, tibial component and femoral component were returned for evaluation.Two pegs of the tibia were found to be broken.Both surfaces of the tibia exhibit foreign material and the inferior surface of the tibia exhibit dings and minor scratches.Superior side of the plastic part exhibit pitts and gouges while the inferior surface was deformed.Inferior side of the femoral component exhibit foreign material and returned parts were not in a condition to perform dimensional analysis.This information does not change the previously identified root cause 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.

• Brand Name: PERSONA POROUS 2 PEG TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6136546
• MDR Text Key: 61164180
• Report Number: 0001822565-2016-04423
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42530007102
• Device Lot Number: 62657579
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 96