MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B RM PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling/ Edema (4577)

Event Date 10/12/2018

Event Type  Injury  

Event Description

It was reported that the patient underwent a partial knee replacement.Subsequently, the patient was revised due to loosening of the tibial component, approximately 10 months post implantation.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number: 159575, item name: oxf anat brg rt md size 3 pma, lot number: 365570; catalog number: 161469, item name: oxf twin-peg cmntd fem md pma, lot number: 502190; catalog number: unknown cement, item name: unknown, lot number: unknown.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 will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.The reported products were reviewed for compatibility with no issues noted.Medical records / radiographs were provided and reviewed by a healthcare professional.Review of the available records identified the following: end stage osteoarthritis, degenerative joint disease are likely contributing factors.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXF UNI TIB TRAY SZ B RM PMA
• 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: 15081652
• MDR Text Key: 296371559
• Report Number: 3002806535-2022-00325
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388875
• UDI-Public: (01)05019279388875(17)270909(10)814690
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154721
• Device Lot Number: 814690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2017
• 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; Other
• Patient Sex: Female
• Patient Weight: 123 KG