MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD PHASE III FEMORAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product: unknown oxford phase iii bearing, cat#: unknown lot#: unknown; unknown oxford phase iii tibial component, cat#: unknown lot#: unknown.Initial reporter: r.H.Emerson, o.Alnachoukati, j.Barrington, k.Ennin ¿the results of oxford unicompartmental knee arthroplasty in the united states¿ bone joint j.2016; 98-b (10 suppl.B); 34-40.The reported event was unable to be confirmed due to limited information received from the customer.A device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A complaint history review was unable to be performed as the part and lot numbers are unknown.A 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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2017-00842, 3002806535-2017-00843, 3002806535-2017-00844.Product location unknown.

Event Description

It was reported in a journal article that one patient was revised due to chronic haemathrosis.No additional patient consequences were reported.

• Brand Name: UNKNOWN OXFORD PHASE III FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6789960
• MDR Text Key: 82565035
• Report Number: 3002806535-2017-00844
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention