MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL SM; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported that there was a fire at the hospital on (b)(6).The whole inventory of implants was affected in the event.Most of the implants were not a part of the fire but because of water/smoke they were all moved to quarantine area at the hospital.One of the implants from quarantine was used by mistake on a patient as a nurse picked implant from quarantine section.It was further reported that the patient died due to respiratory failure.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found in relation to this reported event.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 that there was a fire at the hospital on march 10th.The whole inventory of implants was affected in the event.Most of the implants were not a part of the fire but because of water/smoke they were all moved to quarantine area at the hospital.One of the implants from quarantine was used by mistake on a patient as a nurse picked implant from quarantine section.It was further reported that the patient died due to respiratory failure.

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL SM
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8673644
• MDR Text Key: 147157547
• Report Number: 3002806535-2019-00486
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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: 166941
• Device Lot Number: J6310650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other