MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL; PROSTHESIS, KNEE

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: event occurred in (b)(6).

Event Description

It was reported that approximately 1 month post implantation, the patient experienced pain and was found to have a tibial bone fracture.The patient has indicated a possible revision, but one has not been confirmed yet.Attempts have been made and no further information has been provided.

Manufacturer Narrative

No devices or photos were received; therefore, the condition of the components is unknown.The dhr was reviewed and no discrepancies relevant to the reported event were found.X-rays evaluation report provided by third party hcp states that there is evidence of a vertically oriented medial tibial plateau fracture and associated subsidence of the tibial component.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: PARTIAL TIBIAL CEMENTED SIZE F LEFT MEDIAL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9672279
• MDR Text Key: 177828522
• Report Number: 0001825034-2020-00490
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00880304812703
• UDI-Public: (01)00880304812703
• Combination Product (y/n): N
• PMA/PMN Number: K161592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42538000601
• Device Lot Number: 64271273
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 60