MAUDE Adverse Event Report: BIOMET UK LTD. RHK BRG 12 FOR 71-75-79 TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/04/2010

Event Type  Injury  

Manufacturer Narrative

The 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 mdrs were filed for this event.Please also see: 001822565-2018-00218; 001822565-2018-00219; 001822565-2018-00220; 3002806535-2018-00633; 3002806535-2018-00634; 3002806535-2018-00636.

Event Description

Information received from national joint registry that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure was performed due to periprosthetic fracture.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated.Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: RHK BRG 12 FOR 71-75-79 TRAY
• 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: 7384427
• MDR Text Key: 103917177
• Report Number: 3002806535-2018-00635
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 159435
• Device Lot Number: 1437568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2008
• 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 Age: 65 YR