MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: oxf anat brg lt md size 5 pma, catalog #: 159549, lot #: 561850, medical product: oxf uni tib tray sz d lm pma, catalog #: 154724, lot #: 342130, medical product: 1/8 quick rel drl sterile 2pk, catalog #: 32-486265, lot #: 765430, medical product: stryker op rcp 76.0x11.7, catalog #: 277325, lot #: 313706, medical product: stryk_76542k_13x90x.89f, catalog #: 13-0900-89y-f1, lot #: 313261.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00034, 3002806535-2020-00035.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to bearing dislocation was performed.

Manufacturer Narrative

(b)(4).A review of the complaint identified that the femoral component below was not reportable, and therefore moved to an associated product.Subsequently, we are voiding this medwatch report: medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 800730.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a the bearing was revised due to dislocation.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9615556
• MDR Text Key: 175832466
• Report Number: 3002806535-2020-00036
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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: 161469
• Device Lot Number: 800730
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• 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