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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Damage to Ligament(s) (1952)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Trieb, k.(2016) rotating-hinge total knee arthroplasty for revision total knee replacement.Orthopaedic proceedings.Event occurred in europe.Reported event was unable to be confirmed as part number / lot number of device involved in the incident 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.

Event Description

It was reported 3 patients underwent knee revision due to ligamentum patellae ruptures.Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN KNEE
• 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: 6549601
• MDR Text Key: 74584713
• Report Number: 3002806535-2017-00290
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PNI
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention