MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL MD; KNEE PROSTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration (4003)

Patient Problem Joint Dislocation (2374)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: unk oxford bearing catalog #: not reported lot #: not reported medical product: unk oxford tibial component catalog #: not reported lot #: not reported.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to aseptic loosening and dislocation of the femoral implant was performed.

Event Description

It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to aseptic loosening and dislocation of the femoral implant was performed.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: medical product: oxf anat brg lt md size 5 pma catalog #: 159549 lot #: 2361707.Medical product: oxf uni tib tray sz d lm pma catalog #: 154724 lot #: 2330295.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee replacement procedure.Subsequently, a revision procedure due to aseptic loosening and dislocation of the femoral implant was performed.

• Brand Name: OXFORD UNI FEMORAL MD
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9166180
• MDR Text Key: 161557517
• Report Number: 3002806535-2019-00814
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 154601
• Device Lot Number: 2395530
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2019
• 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