MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE FIXED BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Weakness (2145); Numbness (2415); Limited Mobility Of The Implanted Joint (2671)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Concomitant medical product: persona fixed bearing articular surface; p/n: 42512401014, l/n: 62199213; persona posterior stabilized femoral; p/n: 42500607001, l/n: 62629231; persona all polyethylene patella; p/n: 42540000038, l/n: 62113096.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.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: 3007963827 - 2019 - 00086, 0002648920 - 2019 - 00240.Product location is unknown.

Event Description

It was reported that the patient underwent a revision procedure four years post-implantation due to loosening.During the revision procedure, the surgeon noted lack of bony ingrowth and subsidence of the tibial component and bone cement present on device.

Manufacturer Narrative

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, 3007963827 - 2019 - 00086 - 1, 0002648920 - 2019 - 00240 - 1.

Event Description

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

• Brand Name: ARTICULAR SURFACE FIXED BEARING
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8468988
• MDR Text Key: 140440426
• Report Number: 0001822565-2019-01316
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• PMA/PMN Number: K121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 42512401014
• Device Lot Number: 62199213
• 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