MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; KNEE ARTHROPLASTY

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: oxf anat brg lt lg size 4 pma, catalog #: 159555, lot #: 550910.Medical product: oxf uni tib tray sz c lm pma, catalog #: 154722, lot #: 966630.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00020, 3002806535-2021-00022.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on an (b)(6) 2020.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2021.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on an (b)(6) 2020.Subsequently, a revision procedure due to implant fracture was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00020-1, 3002806535-2021-00022-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with these items159555 and 161470.A review of the complaint database over the last 3 years has found 1 similar complaints reported with the item 154722.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.Risk management report documents the estimated residual risk associated with the device within the reported event.The reported event states revision due to fall causing implant fracture.This incident has a severity score of 3 which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11228540
• MDR Text Key: 228705211
• Report Number: 3002806535-2021-00021
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: 05019279438259
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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: 161470
• Device Lot Number: 497060
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention