MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT X-SM 3MM PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Associated products: medical product: oxf uni tib tray sz aa rm pma, catalog #: 159532, lot #: 434130; medical product: oxf twin-peg cmntd fem xs pma, catalog #: 161467, lot #: 360490.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, an irrigation and debridement of oxford partial knee with poly revision was performed.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty.Subsequently, an irrigation and debridement of oxford partial knee with poly revision was performed.

Manufacturer Narrative

(b)(4).D11: associated products: medical product: oxf uni tib tray sz aa rm pma, catalog #: 159532, lot #: 434130; medical product: oxf twin-peg cmntd fem xs pma, catalog #: 161467, lot #: 360490.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 no similar complaints reported with these items.The sterile certificate confirm product received adequate amount of radiations and sterilized according to standard specification.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 ANAT BRG RT X-SM 3MM PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10384526
• MDR Text Key: 202183382
• Report Number: 3002806535-2020-00371
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279073016
• UDI-Public: 05019279073016
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 160790
• Device Lot Number: 864580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization