MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD TIBIAL COMPONENT; HIP PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: unk oxford femoral component, catalog #: unknown, lot #: unknown; medical product: unk oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00665, 3002806535-2019-00667.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee procedure.Subsequently, the patient was revised due to tibia loosening.

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.A handwritten note on the oxford partial knee warranty claim form indicates the patient was 6¿3 tall and weighed (b)(6), thus having a bmi of 27.5 (overweight).It is stated in communications with a sales representative that 'the tibia wasn¿t terribly loose but could have been the problem'.Loosening of the tibial component could not be confirmed in this instance without provision of further radiographic, patient and surgical information, as well as of the revised components.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 a patient underwent an initial right knee procedure.Subsequently, the patient was revised due to tibia loosening.

• Brand Name: UNK OXFORD TIBIAL COMPONENT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8891772
• MDR Text Key: 154253668
• Report Number: 3002806535-2019-00666
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 08/28/2019
• 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
• Patient Weight: 100