MAUDE Adverse Event Report: ZIMMER INC PERSONA TMTWO-PEGGED POROUS TIBIA - LEFT SIZE D; KNEE PROSTHESIS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); No Information (3190)

Event Date 12/12/2015

Event Type  Injury  

Event Description

It is reported that the pt is experiencing loosening.

Manufacturer Narrative

No devices or photos were received; therefore the condition of the components is unk.Surgical notes were not provided; it is unk whether the components were implanted with the correct fit and orientation as per the surgical technique.Device history records could not be reviewed as the part and lot numbers are unk.A definitive root cause cannot be determined with the info provided.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is now known that the patient was revised for unknown ongoing problems.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

Medical product - persona ultracongruent fixed articular surface - left 11mm, item #: 42512200411, lot #: 62590682.Persona tapered cemented stem extension - 14 mm diameter, +30 mm length, item #: 42557000114, lot #: 63177002.Nexgen tm standard primary patella, item #: 00587806535, lot #: 62617948.Persona tm cruciate retaining narrow porous femoral, item #: 42502206001, lot #: 62706192 (b)(4).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 has now been reported that the patient underwent revision of her tibial component due to indications of loosening.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of op notes.Device history record was reviewed and no discrepancies relevant to the reported event were found.The problem with this device constitutes a "design issue" as the 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.

Event Description

Review of the revision operative notes indicates that no evidence of any significant problems on her x-ray but continued discomfort to the point where she was having as much pain as she was having preoperatively.It was felt that this was due to loosening of her tibial component.While removing tibial component, it was found that lateral peg was solidly fixed.The medial peg was not as solidly fixed as the lateral peg, and came out much easier.

• Brand Name: PERSONA TMTWO-PEGGED POROUS TIBIA - LEFT SIZE D
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582-0708 ; 5745273773
• MDR Report Key: 4817843
• MDR Text Key: 5929423
• Report Number: 1822565-2015-00806
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 42530006701
• Device Lot Number: 62522564
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1266-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 68