MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD ARTICULATING SURFACE; PROSTHESIS, KNEE

Catalog Number UNKNOWN

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Insufficient Information (4580)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).G2-foreign-australia.D10.Item#:unknown; lot#:unknown ;item name: unknown oxford cemented femur; item#:unknown; lot#:unknown ;item name: unknown oxford cemented tibia; h3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00316, 3002806535 - 2023 - 00317.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient underwent revision surgery due to poly wear, pain and instability.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause cannot be determined.

• Brand Name: UNKNOWN OXFORD ARTICULATING SURFACE
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 17817337
• MDR Text Key: 324250805
• Report Number: 3002806535-2023-00318
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 76 KG