MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL COMPONENT; PROSTHESIS, KNEE

Catalog Number UNKNOWN

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

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Medical product: item#:unknown ;lot#: unknown ;item name: unknown oxford femoral component; item#:unknown ;lot#: unknown ;item name: unknown oxford bearing ; item#:unknown ;lot#:unknown ;item name: unknown refobacin bone cement r; therapy date: unknown.H3-other: device evaluation could not be performed as part# and lot# unknown.Also device location is unknown.G2-foreign- italy.G2-literature- journal article.No difference in mobile and fixed bearing partial knee arthroplasty in octogenarians: a clinical trial (2023).Riccardo d¿ambrosi, federico valli, alessandro nuara, ilaria mariani, fabrizio di feo, nicola ursino, matteo formica, laura mangiavini, michael hantes, filippo migliorini.Https://doi.Org/10.1007/s00590-023-03537-7.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00404.3002806535 - 2023 - 00406.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.

Event Description

The study reported two patients were revised due to aseptic loosening.Due diligence is completed for this complaint; to date whatever additional information received has been captured in the complaint.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• 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: 18254199
• MDR Text Key: 329548022
• Report Number: 3002806535-2023-00405
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/15/2023
• 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 Sex: Prefer Not To Disclose