MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C RM PMA; OXFORD CEMENTED TIBIAL TRAYS

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/09/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Concomitant medical products: the product has not been returned to zimmer biomet for investigation.Medical product: oxf anat brg rt md size 5 pma, catalog #: 159577, lot #: 2358861.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 145650.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00174, 3002806535-2021-00175.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 right knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00174-1, 3002806535-2021-00175-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found (b)(4) complaints reported with the item159577, (b)(4) complaints reported with the item 161469 and (b)(4)complaints reported with the item 154723.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF UNI TIB TRAY SZ C RM PMA
• Type of Device: OXFORD CEMENTED TIBIAL TRAYS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11804790
• MDR Text Key: 249939642
• Report Number: 3002806535-2021-00176
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 154723
• Device Lot Number: 058170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2021
• 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 Age: 65 YR