MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD BEARING; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/12/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it location unknown.Medical product: unk oxford femoral component, catalog #: unk, lot #: unk.Medical product: unk oxford tibial component, catalog #: unk, lot #: unk.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00238, 3002806535-2021- 00239.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

On (b)(6) 2014 the initial surgery was to take place, however the sales rep informed the doctor that the hardware was for the medial side of the knee.Dr.(b)(6) of (b)(6) orthopaedics and sports medicine pc then decided to perform a left lateral femoral condyle microfracture operation, when hardware from another vendor could not be obtained.(this event was previously report under mfr report no.3002806535 -2021 -00230/00231/00232).The partial knee replacement of the lateral compartment of the left knee was then rescheduled for (b)(6) 2014.This operation was rescheduled for (b)(6) 2014 as it could not take place as the patient suffered from an infection at the incision site.During scheduled revision surgery on (b)(6) 2014 by dr.(b)(6), it was discovered that the wrong hardware was present.The doctor closed the wound and explained to the patient the operation would have to be postponed for a day or two for the correct hardware.This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Event Description

It was reported that the patient was suffering from left knee pain.Dr.(b)(6)recommended a partial knee replacement of the lateral compartment of the left knee.A surgical plan/ knee implant hardware request was submitted to biomet.The plan/ hardware request however was completed for the left knee medial compartmental surgery and component hardware.On (b)(6), 2014 the initial surgery was scheduled to take place.It was only then, when the sales representative informed the doctor that the hardware was for the medial side of the knee, that dr.(b)(6) realised that the appropriate hardware for the procedure was not present.Dr.(b)(6) then decided to perform a left lateral femoral condyle microfracture operation, when hardware from another vendor could not be obtained.- (b)(4).The partial knee replacement of the lateral compartment of the left knee was then rescheduled for (b)(6), 2014.This operation was rescheduled for (b)(6), 2014 as it could not take place as the patient suffered from an infection at the incision site.During surgery on (b)(6), 2014, it was discovered that the wrong hardware was present.The doctor closed the wound and explained to the patient that the operation would have to be postponed for a day or two in order for the correct hardware to arrive.- (b)(4).This report is based on allegations set forth in patients notice and the allegations there in are unverified.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00238-1, 3002806535-2021- 00239-1.The product has not been received for evaluation.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information a review of the manufacturing history records could not be performed as item numbers and lot numbers are unknown.A review of the complaint database could not be performed as item numbers and lot numbers are unknown.During surgery, it was discovered that the wrong devices were present.The root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

• Brand Name: UNKNOWN OXFORD BEARING
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11893312
• MDR Text Key: 252915116
• Report Number: 3002806535-2021-00237
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• 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: UNK OXFORD BEARING COMPONENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Other