MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN PEG CMNTLS FMRL MD; PROSTHESIS, KNEE

Catalog Number 161474

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint Dislocation (2374); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10.Item#:159547 ;lot#:679030 ;item name: oxf anat brg lt md size 3 pma; multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00353.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 due to pain and instability.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Event Description

It was reported that the patient underwent revision due to pain, loosening, dislocation and metallosis.

Manufacturer Narrative

(b)(4).D10: item#:159547 ;lot#:371130 ;item name: oxf anat brg lt md size 3 pma; visual examination of the returned product identified nicks, gouges and wear on the surface of the bearing component.The femoral component appears to have some scratches to the bearing surface and some bone ongrowth to the porous surface.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified aseptic loosening.Hemorrhage observed with what appeared to be some metallos in addition to a significant amount of scar on the anterior flange.When the knee was flexed to remove the bearing, the bearing was levered up and the femur "popped off.".No evidence of bony ingrowth on the back of the femur with posterior condyle showing no evidence of lytic areas and with bone intact without defects.With the available information, a definitive root cause could not be determined.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.

• Brand Name: OXF TWIN PEG CMNTLS FMRL MD
• 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: 17985181
• MDR Text Key: 326300438
• Report Number: 3002806535-2023-00352
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279442270
• UDI-Public: (01)05019279442270(17)251113(10)R2503466A
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 161474
• Device Lot Number: R2503466A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• 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?: Yes
• Date Device Manufactured: 11/13/2015
• 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): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 105 KG