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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Report source: (b)(6).Concomitant medical products: medical product: unk oxford bearing catalog #: not reported lot #: not reported, medical product: unk oxford femoral component catalog #: not reported lot #: not reported.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported by the sales representative that a patient underwent initial knee arthroplasty on (b)(6) 2019.Subsequently, the tibial fractured with subsidence of the component.This was identified with x-rays after the patient complained about pain.A revision surgery is planned.

Event Description

It was reported by the sales representative that a patient underwent initial knee arthroplasty.Subsequently, the tibial fractured with subsidence of the component.This was identified with x-rays after the patient complained about pain.A revision surgery is planned.

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.Radiological images: three anteroposterior radiographs were provided for analysis with (b)(4): one pre-primary surgery; one post-primary surgery; and one pre-revision (after fracture of tibial plateau).Exact dates of the radiographs have not been provided.In the post-primary x-ray, the tibial tray is overhanging from the medial side of the tibial plateau.The oxford partial knee surgical technique states that the medial edge of the tibial tray should be flush with (or have less than 2 mmm overhang from) the medial edge of the tibial plateau.The zper states that the surgical technique for the product was utilised.The post-primary x-ray suggests that a thick bearing has been used, which may have required a more distal tibial bone resection than necessary.This cannot be confirmed without part and lot numbers, mediolateral x-rays, surgical notes and additional information related to patient¿s post-operative activity level.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 TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9436659
• MDR Text Key: 169808014
• Report Number: 3002806535-2019-00914
• 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
• Report Date: 12/19/2019

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?: 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
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 11/30/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization