MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ E LM PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 366700; oxf anat brg lt md size 5 pma, catalog #: 159549, lot #: 473440.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00670, 3002806535-2019-00672.Product was discarded.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that a patient underwent revision to a thicker bearing due to dislocation of the polyethylene component.Subsequently, the patient experienced an additional dislocation resulting in a revision to a total knee arthroplasty.

Event Description

It was reported by the hospital that a patient underwent revision to a thicker bearing due to dislocation of the polyethylene component.Subsequently, the patient experienced an additional dislocation resulting in a revision to a total knee arthroplasty.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.Three radiographs were taken; one anteroposterior, one mediolateral and one skyline view.All x-rays show that the anatomical bearing has dislocated from the articulating surfaces into the anterior joint space.In the mediolateral x-ray, the tibial tray appears short of the posterior edge of the tibial plateau.The oxford partial knee surgical technique states that the posterior edge of the tibial tray should be flush with (or have less than 2 mm overhang from) the posterior edge of the tibial plateau.Surgical notes from the bearing revision surgery (22nd may 2019) state that 'the final 5 mm implant bearing was snapped into place.The knee was taken through a full range of motion with excellent mobility of the implant, no instability whatsoever of the knee.The implant could not be subluxated or dislocated and in fact the implant was somewhat difficult to get in the first place'.It is not possible to comment on implant positioning and bearing thickness without radiographs from after primary surgery.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: OXF UNI TIB TRAY SZ E LM PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8891921
• MDR Text Key: 154258536
• Report Number: 3002806535-2019-00671
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388929
• UDI-Public: 05019279388929
• 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: 09/12/2019

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: 154726
• Device Lot Number: 734910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/12/2019
• 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: 105