MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Information (3190)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Unique identifier (udi) number: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to their hospital policy.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product: oxf twin-peg cmntd fem md pma, catalog: 161469, lot: 858740.Medical product: oxf anat brg rt md size 6 pma, catalog:159578, lot: 592020.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 an initial knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This report to be voided.On jan 08, 2021, we identified that (b)(4) is duplicate of (b)(4).(b)(4) is to be made not a complaint, therefore, this report is to be voided.The reported event in respect of (b)(4) is reported under 3002806535-2020-00548 and 3002806535-2020-00548-1.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.

• Brand Name: OXF UNI TIB TRAY SZ D RM PMA
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11071286
• MDR Text Key: 223599623
• Report Number: 3002806535-2020-00559
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 050192793888912
• UDI-Public: (01)050192793888912(17)290130(
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• 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: 154725
• Device Lot Number: 134570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• 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: 92