MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA TIBIA TRABECULAR METAL MODULAR TIBIA; PROSTHESIS KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Unstable (1667); Failure to Osseointegrate (1863); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Numbness (2415); Limited Mobility Of The Implanted Joint (2671); No Information (3190)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: articular surface fixed bearing posterior stabilized (ps) left 14 mm height catalog # 42512401014 lot # 62199213, femur cemented posterior stabilized (ps) standard left size 11 catalog # 42500607001 lot # 62629231.Product will not be returning to zimmer biomet for investigation because surgeon did not approve for implant return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Surgeon didn't approve for return.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, the patient was revised due to loosening.

Event Description

It was further reported during the revision procedure, the surgeon noted lack of bony ingrowth and subsidence of the tibial component.

Manufacturer Narrative

Concomitant medical products: persona all polyethylene patella, catalog #: 42540000038, lot #: 62113096.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.

Manufacturer Narrative

Concomitant medical products: palacos bone cement, catalog #: 00111314001, lot #: 77884368.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 further noted that patient had mild swelling approximately eight weeks post-initial implantation and continued to have one year post-initial implantation with effusion noted.The patient was also noted to have felt "like he pulled something and feels fluid behind the knee" approximately one year post-implantation.Finally, one year post-implantation the patient also noted sharp pain in the morning.Approximately three years post-implantation, the patient was noted to have moderate to severe pain which is aggravated by physical activity, twisting, stairs and prolonged walking and standing.The symptoms are associated with muscle calf weakness, hyper extension, painful range of motion, difficulty arising from a chair and vehicle, and using stairs.The patient is noted to have varus thrust with walking and mild varus upon exam.It was further reported the revision procedure was performed as patient also had pain, swelling, instability, painless popping and clicking, locking, catching, numbness, and dysfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of two-peg trabecular metal tibia, from the picture provided exhibits sign of being implanted with one peg was covered with soft tissues than other peg.Primary surgical notes was provided and found no complication noted.The x-ray was provided and review was performed by third party hcp.The review states loosening and radiolucency along tibia plate.Dhr was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the reported event was due to design deficiency.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: 0001822565 - 2018 - 01302 - 3 0001822565 - 2018 - 02467 - 1 0001822565 - 2019 - 01316 - 1 3007963827 - 2019 - 00086 - 1 0002648920 - 2019 - 00240 - 1.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA TIBIA TRABECULAR METAL MODULAR TIBIA
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7311107
• MDR Text Key: 101458906
• Report Number: 0001822565-2018-01302
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK173417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 42530008301
• Device Lot Number: 62438493
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 103