MAUDE Adverse Event Report: BIOMET UK LTD. UNK POLY BIOMET OXFORD MEDIAL ANATOMIC MEDIUM 3MM; KNEE PROSTHESIS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Failure of Implant (1924)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10 - medical devices: unk femoral biomet oxford twin pegged cementless sz.M; item# unknown, lot# unknown.Unk tibia biomet oxford medial cementless sz.D; item# unknown, lot# unknown.H3 - product was discarded.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Product is unknown.

Event Description

It was reported that a patient had undergone left unicompartmental knee surgery.Subsequently, the patient developed a hematoma, which was successfully resolved with the use of compression wraps.Additionally, the patient underwent a revision surgery to repair a capsular defect that occurred after kneeling on the operated knee.A poly exchange was performed, and no additional information was provided.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4).Given this information, this medwatch will be voided.

Event Description

Upon reassessment of the reported event, it was determined a medwatch report should not have been filed under the current manufacturer as the complaint is a duplicate of (b)(4)- mdr report number 3002806535-2019-00104 - mdr report number 3002806535-2019-00104.Given this information, this medwatch will be voided.

• Brand Name: UNK POLY BIOMET OXFORD MEDIAL ANATOMIC MEDIUM 3MM
• Type of Device: KNEE PROSTHESIS
• 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: 17994101
• MDR Text Key: 326350465
• Report Number: 3002806535-2023-00356
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN OXFORD BEARING
• 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: 10/25/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 108 KG