MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN AGC BEARING; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Unstable (1667)

Patient Problem Osteolysis (2377)

Event Date 08/28/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history records review was unable to be performed as the lot number of the device involved in the event is unknown.Complaint history could not be conducted as the product identification is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 mdrs were filed for this event, please see associated reports: 3002806535-2017-00334, 3002806535-2017-00335, 3002806535-2017-00336, 3002806535-2017-00337.

Event Description

It was reported the patient underwent a left knee arthroplasty.Subsequently, the patient underwent a revision procedure due to aseptic loosening of the femoral, tibial, and patellar components, implant fracture, instability, lysis of the femur and tibia, and wear of the poly bearing.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

• Brand Name: UNKNOWN AGC BEARING
• 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: 6564299
• MDR Text Key: 75061761
• Report Number: 3002806535-2017-00335
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2017

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN AGC FEMORAL; UNKNOWN AGC PATELLA; UNKNOWN AGC TIBIAL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR