MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D LM PMA; KNEE PROTHESIS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: medical product: unk oxford femoral component, catalog #: unknown, lot #: unknown, medical product: unk oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00032, 3002806535-2020-00033.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00032-1, 3002806535-2020-00033-1.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.There were no trends identified from the complaint history review.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure was performed due to the patient developing gout.

Manufacturer Narrative

(b)(4).This final/follow-up report is being submitted to relay additional information.D11: medical product: oxf twin-peg cmntd fem md pma, catalog#: 161469, lot#: 540420.Medical product: oxf anat brg lt md size 4 pma, catalog#: 159548, lot#: 230390.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00032-2, 3002806535-2020-00033-2.Initial and revision procedures were performed at different hospital, within the same hospital system, by the same surgeon.Reason for revision: gout development in patient.As the product has not been received, the investigation was limited to the information provided.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A risk assessment has not been performed for the reported event as disease progression (gout) is not device-related.A review of the complaint database has found 1 similar complaint for the item code: 154724, 6 similar complaints for the item code: 161469 and no similar complaints reported with the item: 159548.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in the cause.In most cases of similar complaints, the cause could not be established.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.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.

Event Description

It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure was performed due to gout development in patient.

• Brand Name: OXF UNI TIB TRAY SZ D LM PMA
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9615415
• MDR Text Key: 175838497
• Report Number: 3002806535-2020-00031
• Device Sequence Number: 1
• Product Code: NRA
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 154724
• Device Lot Number: 117760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/23/2020; 01/27/2020
• Supplement Dates FDA Received: 02/17/2020; 02/26/2020
• 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