MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL SM; KNEE ARTHROPLASTY

Model Number N/A

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: oxf fix lat brg c3 left, catalog #: 154330, lot #: 197660 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient who underwent lateral uka on (b)(6) 2020 was postoperatively suspected of infection.At the surgery, tibia component which is subject to a recall product due to unsealed or weak seal pouch (hhe-2020-00316) was implanted.Two additional surgeries were performed.The first time, cleaning and antibiotic administration were performed, and the second time was continuous cleaning.However, the infection has not been cured and the patient keeps being treated now.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: medical product: oxf fix lat brg c3 left, catalog #: 154330, lot #: 197660.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.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 review of sterile certificate indicated that product received radiation within specified range.A review of the complaint database over the last 3 years has found 1 complaint(cmp-0661761- initiating complaint) reported with the item 166941.The item/lot combination of the femoral detailed in this complaint was not within scope of hhe-2020-00316, as detailed in the complaint description.However, the bearing component that was implanted at the same time as the femoral component, which is being investigated under cmp-0656101, is within scope of hhe-2020-00316.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.Risk assessment: the event reports infection which resulted in further surgery to clean the joint and administer antibiotics.Revision surgery has not been reported.Multiple hazards (lines) within the oxford cemented implant risk table include a harm of infection, moderate localized, with a severity score of 3 and an occurrence score of (b)(4).Severity assessment: the event reports that further surgery to clean the joint and administer antibiotics was required, this gives a severity score of 3 which is in line with the risk file.Occurrence assessment: sales data period-jan 2017 to jan 2021 (most up to date sales data available).Number of sales - (b)(4).Complaint data period - jan 2017 to 05 march 2021 (current date).Number of complaints - (b)(4).Occurrence ration -(b)(4).Occurrence score - (b)(4).

Event Description

It was reported that patient who underwent lateral uka on 13th oct, 2020 was postoperatively suspected of infection.At the surgery, tibia component which is subject to a recall product due to unsealed or weak seal pouch (hhe-2020-00316) was implanted.Two additional surgeries were performed.The first time, cleaning and antibiotic administration were performed, and the second time was continuous cleaning.However, the infection has not been cured and the patient keeps being treated now.

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL SM
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11160525
• MDR Text Key: 228625888
• Report Number: 3002806535-2021-00016
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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: 166941
• Device Lot Number: J6817439
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 70