MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT S L; KNEE PROSTHESIS

Model Number N/A

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in the (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: unknown oxford bearing s4, catalog #: not reported, lot #: not reported; unknown oxford tibial component s e, catalog #: not reported, lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00691, 3002806535-2019-00693.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 hospital that a patient underwent an initial left knee replacement surgery.Subsequently, a revision procedure was performed due to progression of oa and pain.During operation bearing was found to be fractured with metallosis in the joint.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.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.

Event Description

It has been reported by the hospital that a patient underwent an initial left knee replacement surgery.Subsequently, a revision procedure was performed due to progression of oa and pain.During operation bearing was found to be fractured with metallosis in the joint.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT S L
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8919929
• MDR Text Key: 155167328
• Report Number: 3002806535-2019-00692
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention