MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 5 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

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.Associated products: medical product: oxf uni tib tray sz c rm pma, catalog no.: 154723, lot no.: 6866804.Medical product: oxford uni twin-peg femoral sm, catalog no.: 166941, lot no.: 6716013.Medical product: oxf anat brg rt sm size 5 pma, catalog no.: 159570, lot no.: 6474885.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned.

Event Description

It was reported, that due to right knee osteoarthritis, the patient underwent right knee joint cleaning and artificial singlecondyle joint replacement in our hospital on (b)(6) 2021.The operation was successful and the postoperative recovery was good.14 days after the operation, the patient's body temperature increased to 38.5° after the cold, followed by the redness, swelling, heat and pain of the right knee joint, joint movement was limited, and the local hospital received anti-inflammatory treatment, but the effect was not good.He went to our hospital for treatment at (b)(6) 2021.After admission, he received joint fluid culture and antibiotic therapy (vancomycin and meropenem).After surgical contraindications were eliminated, right knee debridement and single-condylar system liner replacement was performed on (b)(6) 2021.The operation was successful, and local intraarticular antibiotic injection (vancomycin and meropenem) and systemic intravenous antibiotic therapy (vancomycin) were performed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No devices were received; therefore the condition of the components is unknown.Review of the device history record has identified no related deviations or anomalies during manufacturing related to the reported event.The sterilisation certificate for item #159570, lot #6474885 was reviewed.The sterilisation certificate for this lot number was found from sap to be certificate number ¿4200049825'.The supplied gamma irradiation dose was found to be between 30.3 kgy and 32.1 kgy, which is within the specification of 29.1 to 34.1 kgy.This device is used for treatment.No compatibility issues were noted.A review of complaint history was assessed for three years prior to the notification date and identified (2) total complaints for item #159570 (including initiating complaint).There were (0) additional complaints against the lot #6474885.Initial op notes were reviewed and no complications were noted.Revision op notes were reviewed and identified the following: when the liner was removed, the posterior joint capsule was seen to be filled with scar and pseudomembranous tissue; the suspected infected tissue was visible to the naked eye; the surface of the prosthesis was brushed several times with a toothbrush to destroy the biofilm.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.In this case, it is noted that the patient was suffering from a cold at the time of the reported event.Based on the available data, the root cause of the event was unable to be determined.However, there is no evidence that the product contributed to the reported infection.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

Event Description

It was reported, that due to right knee osteoarthritis, the patient underwent right knee joint cleaning and artificial single condyle joint replacement in our hospital on (b)(6) 2021.The operation was successful and the postoperative recovery was good.14 days after the operation, the patient's body temperature increased to 38.5° after the cold, followed by the redness, swelling, heat and pain of the right knee joint, joint movement was limited, and the local hospital received anti-inflammatory treatment, but the effect was not good.He went to our hospital for treatment at (b)(6) 2021.After admission, he received joint fluid culture and antibiotic therapy (vancomycin and meropenem).After surgical contraindications were eliminated, right knee debridement and single-condylar system liner replacement was performed on (b)(6) 2021.The operation was successful, and local intraarticular antibiotic injection (vancomycin and meropenem) and systemic intravenous antibiotic therapy (vancomycin) were performed.

• Brand Name: OXF ANAT BRG RT SM SIZE 5 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12545724
• MDR Text Key: 273740160
• Report Number: 3002806535-2021-00420
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786169
• UDI-Public: 05019279786169
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: N/A
• Device Catalogue Number: 159570
• Device Lot Number: 6474885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Age: 58 YR