MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD FEMORAL COMPONENT; KNEE PROSTHESIS

Model Number N/A

Device Problem Collapse (1099)

Patient Problem Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Concomitant medical products: medical product: unk oxford tibial tray catalog #: not reported lot #: not reported, medical product: unk oxford bearing catalog #: not reported lot #: not reported.Additional mdr report were filed for this event, please see associated report: 3002806535-2019-00912.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It has been reported by the sales representative that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, during regular follow up six weeks post-operative it was noticed that the cemented oxford prosthesis had collapsed for an unknown reason.A revision surgery has been planned for an unknown date.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00912-2.Reported event was unable to be confirmed due to limited information received from the customer.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.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 has been reported by the sales representative that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, during regular follow up six weeks post-operative it was noticed that the cemented oxford prosthesis had collapsed for an unknown reason.A revision surgery has been planned for an unknown date.

Event Description

It has been reported by the sales representative that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, during regular follow up six weeks post-operative it was noticed that the cemented oxford prosthesis had collapsed for an unknown reason.A revision surgery has been planned for an unknown date.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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: UNK OXFORD FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9436546
• MDR Text Key: 169806438
• Report Number: 3002806535-2019-00913
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization