MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TIB BRG MED SZ6; KNEE PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Information (3190)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxford uni femoral md item #: 154601 lot #: 1230424, medical product: oxford uni tib tray44x28 llrm item #: 154610 lot #: 1157476, associated product: cobalt-g hv bone cement 40gm b.Item #: 402433.Lot #: 974350.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00560, 3002806535-2019- 00562.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent right knee arthroplasty.Subsequently, the patient is schedules to be revised due to her knee locking up.

Event Description

It was reported that a patient underwent right knee arthroplasty.Subsequently, the patient is scheduled to be revised due pain and knee locking up.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, h1, h2, h3, h6.The visual investigation confirmed the reported event.The cement mantle was found to be uneven but well attached to the tibial and femoral components, covering most of the non - articulatingsurface and slightly overhanging from the cement pocket.There is little evidence of bone integration on tibial tray and the femoral component.There are light scratches on the articulating surface of the femoral component.Deep scratches are visible on the articulating surfaces of the tibial tray, the surface damage could have appeared during implant removal.Considering that the implant was in use for over 12 years the polyethylene bearing is in overall good condition.Some pitting and light starches are observed on the bearing surface, this indicates that there might have been some third bodies present in the joint space, however this cannot be confirmed without radiographic images.The root cause of the reported event could not be determined from the information provided in the complaint.Device history record (dhr) was reviewed and no discrepancies were found.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 patient underwent right knee arthroplasty.Subsequently, revision surgery performed due pain.

• Brand Name: OXFORD UNI TIB BRG MED SZ6
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8751949
• MDR Text Key: 149757256
• Report Number: 3002806535-2019-00563
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388356
• UDI-Public: 05019279388356
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2020

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 Expiration Date: 05/31/2011
• Device Model Number: N/A
• Device Catalogue Number: 154629
• Device Lot Number: 1183029
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 09/17/2019; 01/28/2020
• Supplement Dates FDA Received: 09/17/2019; 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 100