MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Rash (2033)

Event Date 05/13/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product was not returned for evaluation due to unknown location.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation: under possible adverse effects: ¿valgus-varus deformity, inadequate range of motion due to improper selection or positioning of components, and fatigue fracture of components can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.¿ this product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under pma number p010014.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 underwent left partial knee arthroplasty on (b)(6) 2009.Subsequently, patient was in a motor vehicle accident and fractured tibial plateau and experienced subsidence of tibial component.The knee had fifteen degree fixed flexion and severe varus.Patient then experienced pain for three years until undergoing revision on (b)(6) 2015.Additional information reports that the patient experienced a facial rash on (b)(6) 2013.The issue was not mentioned at a follow up appointment, so it was said to be resolved on (b)(6) 2014.

• Brand Name: OXF ANAT BRG LT LG SIZE 4 PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6934433
• MDR Text Key: 89158018
• Report Number: 0001825034-2017-08224
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 1710135
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100