MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS ANATOMIC ARCOM MENISCAL BRG; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Medical product: oxford uni twin-peg femoral xs, catalog #: 166940, lot #: 6193650; medical product: oxf uni tib tray sz aa rm pma, catalog #: 159532, lot #: 3972454.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00170, 3002806535-2020-00172.Postal code: (b)(6).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 was admitted due to "osteonecrosis of the femoral condyle in the left knee" and underwent "left total knee arthroplasty".The operation was successful and the patient's life signs were normal on (b)(6).The wound dressing was clean.On (b)(6) 2019 the patient came to the hospital and reported that he still could not walk normally or stand upright, which affected his life.Subsequently, the patient was admitted to the hospital and received symptomatic treatment including anti-inflammatory and analgesic therapy, promoting bone healing and anti-osteoporosis.Treatment: joint loosening training once bid, left knee sandbag pressure straight qd; medication: 10mg alendronate sodium tablet oral qd, 0.1g alendronate sodium tablet oral bid, 240mg glucosamine capsule oral tid, 50mg tramadol capsule oral bid, 0.5g alfa ossificol tablet oral qd, 250ml sodium chloride injection with 100mg bone peptide intravenous infusion qd, 250ml sodium chloride injection with 24mg deer and gourd polypeptide injection intravenous infusion qd.Outcome: the patient showed stable vital signs, significantly relieved the pain of the left knee joint, and was discharged without obvious discomfort.It is recommended to continue the functional exercise of knee joint.

Event Description

It was reported that the patient was admitted due to "osteonecrosis of the femoral condyle in the left knee" and underwent "left total knee arthroplasty".The operation was successful and the patient's life signs were normal on (b)(6).The wound dressing was clean.(b)(6) 2019 the patient came to the hospital and reported that he still could not walk normally or stand upright, which affected his life.Subsequently, the patient was admitted to the hospital and received symptomatic treatment including anti-inflammatory and analgesic therapy, promoting bone healing and anti-osteoporosis.Treatment: joint loosening training once bid, left knee sandbag pressure straight qd; medication: 10mg alendronate sodium tablet oral qd, 0.1g alendronate sodium tablet oral bid, 240mg glucosamine capsule oral tid, 50mg tramadol capsule oral bid, 0.5g alfa ossificol tablet oral qd, 250ml sodium chloride injection with 100mg bone peptide intravenous infusion qd, 250ml sodium chloride injection with 24mg deer and gourd polypeptide injection intravenous infusion qd.Outcome: the patient showed stable vital signs, significantly relieved the pain of the left knee joint, and was discharged without obvious discomfort.It is recommended to continue the functional exercise of knee joint.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in china.D10: customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.D11: medical product: oxford uni twin-peg femoral xs, catalog #: 166940, lot #: 6193650.Medical product: oxf uni tib tray sz aa rm pma, catalog #: 159532, lot #: 3972454.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00170-1, and 3002806535-2020-00172-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Refer action item #ai341825: two radiographs, taken on an unknown date, were provided for analysis with (b)(4): one anteroposterior (ap) and one mediolateral (ml).The left cemented oxford partial knee components appear appropriately sized and positioned, although the poor quality and alignment of the x-rays does not allow a detailed analysis.There appears to be bone cement overhanging the posterior edge of the tibial tray in the ml x-ray.The oxford partial knee surgical technique [1] states that there should be no extruded cement posteriorly to the tibial tray.Surgical notes ((b)(6) 2018) state that the operation was smooth and that knee joint activities is good after completely curing bone cement.There is no mention of removal of excess and/or extruded bone cement.The instructions for use provided with the system also provides the following information [2]: care is to be taken to ensure complete support of all parts of the device embedded in bone cement to reduce the risk of stress concentrations, which may lead to failure of the procedure.Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimise wear of the implant articular surfaces.Implant fracture and loosening due to cement failure has been reported.The patient reported that he still could not walk normally or stand upright three months after the operation, which affected his life.The patient showed significantly relieved the pain of the left knee joint, and was discharged without obvious discomfort after treatment with anti-inflammatory and analgesic therapy, promoting bone healing and anti-osteoporosis.The ultimate cause of (b)(4) cannot be confirmed with the information available at the time of writing this assessment, but the patient seems to have recovered after treatment and was recommended to continue the functional exercise of knee joint.The manufacturing history records (mhrs) for the oxford partial knee femoral component, tibial tray and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found 1 similar complaint for this item code 159532 and no similar complaints found for the items 166940 and 159790.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.The event reports joint loosening training and medical intervention was provided and that the patient responded with significantly relieved pain of the left knee joint, and was discharged without obvious discomfort.Pain is considered harm with a severity of 3 for a number of hazards defined in skn002.Rmr.04 rev 04 as moderate, which is described in the severity table as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of the reported event (medical intervention) therefore is in line with the rmf.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.

• Brand Name: OXFORD PKS ANATOMIC ARCOM MENISCAL BRG
• Type of Device: UNICONDYLAR KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9863697
• MDR Text Key: 190133473
• Report Number: 3002806535-2020-00171
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279068937
• UDI-Public: 05019279068937
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 159790
• Device Lot Number: 6224860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• 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: 65 YR