MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ C LM PMA; OXFORD CEMENTED TIBIAL TRAYS

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00332, 3002806535-2021-00333.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient on clinical study presented for 10 month recheck post op left medial uckr done on (b)(6) 2020.It was reported that the patient tripped and fell onto his left knee.Reported minimal symptoms when up walking, but reports pain and decreased flexion with activities such as stairs, kneeling, and rising from a chair.Subsequently, the patient underwent manipulation under anesthesia (mua) on (b)(6) 2021 which resolved the symptoms.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: no product was returned; visual and dimensional evaluations could not be performed.This device is used for treatment.No compatibility issues were noted.Review of the device history records identified no related deviations or anomalies during manufacturing related to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified no similar complaints for item (b)(4).Six post-primary radiographs were provided for analysis with (b)(4): three radiographs taken on (b)(6) 2020 (one anteroposterior, one mediolateral and one skyline) and three radiographs taken on (b)(6) 2021 (one anteroposterior, one mediolateral and one skyline).Generally, the size, position and alignment of the oxford components appear to be in accordance with the recommendations in the oxford surgical technique.The clinical notes from (b)(6) 2021 confirm x-rays demonstrate findings consistent with medial unicondylar knee replacement.Prosthetic components are in good position and well maintained without evidence of loosening.There is well-preserved lateral and patellofemoral joint space.Sunrise view demonstrates neutral tracking patella.Both mediolateral radiographs show the presence of debris in the posterior joint space, which could be fragments of bone or bone cement.Moreover, these were more noticeable in the mediolateral radiograph taken after the patient suffered from a fall.The patient is male, and at the pre-operative visit ((b)(6) 2020) he was 76 years old with a weight of 210 lbs and a height of 72 inches, thus having a bmi of 28 (overweight).On later visits (((b)(6) 2021), patients weight was 215 lbs, thus having a bmi of 29 (overweight).The koos jr knee survey assessment score was (b)(4) prior to the surgery and was either (b)(4) up to 6 months after surgery.A medical event of swelling occurred on (b)(6) 2020 and was considered to be normal post-operative symptom/observation.Another medical event of fall; decreased range of motion occurred on (b)(6) 2021, followed by the medical event manipulation under anesthesia (mua) on (b)(6) 2021.An adverse event manipulation under anesthesia (mua) with an adverse event code stiffness and diagnosis arthrofibrosis was reported with a date of onset (b)(6) 2021, however this was reported as not related to the joint arthroplasty device and not serious, and was resolved by (b)(6) 2021 with the treatment manipulation under anesthesia (mua) for the patient¿s left knee.The operative report of manipulation under anesthesia (mua) done on (b)(6) 2021 mentions that flexion was limited to approximately 105 degrees and a very gentle pressure was applied over the proximal tibia, and full flexion was readily achieved to 130 degrees of flexion, limited only by calf-to-thigh contact.The clinical notes from patients visit on (b)(6) 2021 mentions that the patient is doing very well and has made great improvements with manipulation under anesthesia.The instructions for use provided with the oxford partial knee components provide the following relevant information: warnings: - care is to be taken to ensure complete support of all parts of the device embedded in bone cement to reduce 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 minimize wear of the implant articular surfaces.Implant fracture and loosening due to cement failure has been reported.- patients should be warned of the impact of excessive loading that can result if the patient is involved in an occupation that includes substantial walking, running, lifting, or excessive muscle loading due to weight that place extreme demands on the knee and can result in device failure or dislocation.Precautions: - excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight, and obesity have been implicated with premature failure of the implant by loosening, fracture, dislocation, subluxation and/or wear.Based on the information available with (b)(6), the patient had a fall approximately 10 months after the unicompartmental arthroplasty of the left knee and presented mild symptoms of pain and decreased range of motion, which were reported as unrelated to the device.Radiographic analysis also observed third body debris in the posterior joint space which may have contributed to the reported tightness in the range of motion.However, these events were successfully resolved by manipulation under anesthesia.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00332-1.3002806535-2021-00333-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : device remains implanted.

Event Description

The patient on clinical study presented for 10 month recheck post op left medial uckr done on (b)(6), 2020.It was reported that the patient tripped and fell onto his left knee.Reported minimal symptoms when up walking, but reports pain and decreased flexion with activities such as stairs, kneeling, and rising from a chair.Subsequently, the patient underwent manipulation under anesthesia (mua) on (b)(6), 2021 which resolved the symptoms.

• Brand Name: OXF UNI TIB TRAY SZ C LM PMA
• Type of Device: OXFORD CEMENTED TIBIAL TRAYS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12265726
• MDR Text Key: 264699391
• Report Number: 3002806535-2021-00334
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388882
• UDI-Public: 05019279388882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• 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: 154722
• Device Lot Number: 672810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 98 KG