MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD FEMORAL COMPONENT; UNKNOWN KNEE ARTHROPLASTY

Model Number N/A

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

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 11/13/2019

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: unknown oxford tibial component, catalog #: unknown, lot #: unknown.Medical product: unknown oxford bearing component, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00054.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

Patient underwent biomet partial knee (oxford) in (b)(6) 2011.Subsequently, the bearing was revised on an unknown date.Patient was told the bearing was quite small, and it was replaced with a thicker one ((b)(4)).Patient continued to have problems and pain.Subsequently, on (b)(6) 2019 underwent revision due to tibial and possible femoral loosening.There was cartridge damage.Revised to total knee, thinks it is biomet as well ((b)(4)).Continues to experience pain and difficulty walking ((b)(4)).This complaint reports the revision due to tibial and possible femoral loosening.

Event Description

Patient underwent biomet partial knee (oxford) in nov 2011.Subsequently, the bearing was revised on an unknown date.Patient was told the bearing was quite small, and it was replaced with a thicker one (b)(4).Patient continued to have problems and pain.Subsequently, on (b)(6) 2019 underwent revision due to tibial and possible femoral loosening.There was cartridge damage.Revised to total knee, thinks it is biomet as well (b)(4).Continues to experience pain and difficulty walking (warsaw, (b)(4)).This complaint reports the revision due to tibial and possible femoral loosening.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been received, the investigation was limited to the information provided 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.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00054-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : item not returned to manufacturer.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• Type of Device: UNKNOWN KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11372123
• MDR Text Key: 233269811
• Report Number: 3002806535-2021-00055
• 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: other
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• 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