MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D RM PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report: we are waiting to be informed whether the product is available to be returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: associated products: medical product: unk oxford bearing, item: unknown lot: unknown.Medical product: unk oxford femoral component, item: unknown lot: unknown.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 knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to make corrections.D11: medical product: oxf anat brg rt md size 6 pma, catalog #: 159578, lot #: 592020.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 858740.Additional information received: a)item and lot numbers of the initial implant products: date of initial surgery (b)(6) 2020.Medium twin-peg femur, part #161469, lot# 858740 (associated device).Size d rm tibial tray, part# 154725, lot# 134570.Size 6mm rm medium bearing, part# 159578, lot# 592020 (associated device).B)was the initial and revision procedures performed at the same hospital and by same surgeon? initial surgery: (b)(6).Revision surgery: (b)(6).C)patient information received: dob: (b)(6) 1965 ,height: 5.5, weight: 203 lbs, bmi: 33.27, normal activity level.D)standard revision of failed implants.E)were there any contributing conditions related to the event? patient noted that she fell in mid august and went to er for bilateral knee pain.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 knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to tibial subsidence was performed on (b)(6) 2020.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D4: udi:(b)(4).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 1 similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found 5 similar complaints reported with the item 154725.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports tibial loosening (reported as subsidence), which resulted in revision surgery.The severity of the reported event is in line with multiple lines on the risk file (loss of fixation).The highest severity score associated with this failure mode is 3 (requires surgical intervention) with an occurrence rate of (b)(4).This event reported that surgical intervention was required.This gives a severity score of 3, which does not exceed the severity score on the relevant line in the risk management file.Occurrence assessment: sales data: (b)(4).Complaints: (b)(4).Occurrence rate: (b)(4).Although the occurrence rate has exceeded the score for a single line, the root cause of the complaints are unknown, therefore it is not practical to compare them all to a single line, and the occurrence rates should therefore not be compared.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.

Event Description

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

• Brand Name: OXF UNI TIB TRAY SZ D RM PMA
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11027829
• MDR Text Key: 222077014
• Report Number: 3002806535-2020-00548
• Device Sequence Number: 1
• Product Code: NRA
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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: 154725
• Device Lot Number: 134570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• 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
• Patient Weight: 92