MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN ROTATING HINGED KNEE SYSTEM; KNEE PROTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Pain (1994); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The outcome of the event is currently unknown.We do expect the return of the product.Once the investigation has been completed, a supplemental mdr will be submitted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Outcome of the event currently unknown.

Event Description

It was reported that the patient suffered with sepsis of left knee on an unknown date in 2012.Information such as the implant date and the outcome of the event is unknown.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Attempts were made to obtain additional information; however, none was available.We have not been provided with any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Event Description

It was reported that the patient underwent bilateral knee prosthesis (sepsis of left knee) in 2012.Subsequently, the patient was recently admitted to the hospital on (b)(6) 2020 for frequent falls due to disabling (dislocation) of his left knee prosthesis, tc and wound to 5th left toe.Emergencies : warm knee with suspicion of effusion, violent pain on passive mobilization.T°37.8°c.Patient in severe sepsis.Left knee prosthesis rhk/oss biomet.Reported incident: sepsis on the left knee, which was diagnosed in unknown date in 2012.Information such as the implant date and the outcome of the event is unknown.

• Brand Name: UNKNOWN ROTATING HINGED KNEE SYSTEM
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11019245
• MDR Text Key: 223443860
• Report Number: 3002806535-2020-00541
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: RHK KNEE
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other