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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: medical product: unknown oxford femoral component, catalog #: unknown, lot #: unknown.Medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020 -00249, 3002806535-2020 -00250.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 right knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2020.Product did not cause injury or death.No infection.Product didn¿t malfunction or fail to perform as intended.No delay.No contributing conditions.Surgical technique was used.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D10: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient requested to keep their parts.D11: medical product: unknown oxford femoral component, catalog#: unknown, lot#: unknown.Medical product: unknown oxford bearing, catalog#: unknown, lot#: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00249-2, 3002806535-2020-00250-2.As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : patient requested to keep their parts.

Manufacturer Narrative

(b)(4).Medical product: unknown oxford femoral component, catalog #: unknown, lot #: unknown medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00249-1, 3002806535-2020-00250-1.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to unknown reason was performed on (b)(6) 2020.Additional information received: it was reported that a patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to bearing dislocation was performed on (b)(6) 2020.Product did not cause injury or death no infection.Product didn¿t malfunction or fail to perform as intended.No delay.No contributing conditions.Surgical technique was used.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10065399
• MDR Text Key: 191274320
• Report Number: 3002806535-2020-00248
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2020
• 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