MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERSONA PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number 42522601010

Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problems Tissue Damage (2104); Osteolysis (2377); No Information (3190)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implanted date: (b)(6) 2015.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2017-00273.

Event Description

It was reported that patient was revised due to tibial loosening.During the procedure it was noticed that the articular surface showed signs of wear.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical product- psn tib stm 5 deg sz g r catalog#: 42532007902 lot#: 62735608.Reported event of bearing wear was able to be confirmed through review of photograph received.Additional complaints could not be confirmed.Product was not received for evaluation.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined.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 was revised due to tibial loosening.During the procedure it was noticed that the articular surface showed signs of wear.Osteolysis and medial bone loss were also noted.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: ZIMMER PERSONA PERSONALIZED KNEE SYSTEM- ARTICULAR SURFACE
• Type of Device: PROSTHESIS, KNEE
• 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: 6531978
• MDR Text Key: 74006433
• Report Number: 0001822565-2017-02866
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

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: Physician
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 42522601010
• Device Lot Number: 62628467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2014
• 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