MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 3 PMA; UNICONDYLAR KNEE PROSTHESIS

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Edema (1820); Swelling (2091); Joint Dislocation (2374)

Event Date 10/19/2020

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 has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The product has been discarded.

Event Description

It was reported that the patient underwent a revision surgery due to dislocation of the mobile bearing of his oxford implant.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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 any supporting documentation which could provide additional information.Radiographs received: two radiographs of a left knee, taken on (b)(6) 2020, were provided for analysis with (b)(4): one anteroposterior (ap) and one mediolateral (ml).The anatomical bearing is visible in the proximal anterior joint space, above the patella, in agreement with the reported issue of bearing dislocation.In the ml x-ray, the tibial and femoral components appear adequately sized and positioned, in agreement with the recommendations in the oxford partial knee surgical technique.However, in the ap x-ray, the tibial tray appears short of the medial edge of the tibial plateau.The oxford partial knee surgical technique states that the medial edge of the tibial tray should be flush with (or have less than 2 mm overhang from) the medial edge of the tibial plateau.A large particle is visible within the posterior joint space (in the ml x-ray), which could be a detached osteophyte, a fragment of bone or of bone cement, or the fabella.The zimmer biomet product experience report (zper) states that the primary surgery was performed on (b)(6) 2015 and that the bearing was revised on (b)(6) 2020, which means it was in use for 5 years and 5 months.The patient, male, was 49 at the time of primary surgery.With a weight of 248 lbs (112.5 kg) and a height of 5ft 9in (1.75 m), the patient has a bmi of 36.6 (obese).The zper further states that the surgical technique for the product was utilized, and that there were no contributing conditions related to the adverse event.Additional information, such as post-primary radiographs and patient activity level, was not available at the time of writing this assessment.The revised bearing, which was 3 mm thick, i.E.The thinnest available, was discarded, and therefore it is not available for analysis.Information regarding the thickness and size of the bearing implanted during revision, or on the presence of any degree of soft tissue laxity in the patient knee, is also required to determine the cause of the bearing dislocation.Surgical notes of both primary and revision surgery have been requested but were not made available.Therefore, it is not possible to determine the cause of the implant failure in this instance.The manufacturing history record (mhr) for the oxford partial knee anatomical bearing has been checked and verifies that the component was manufactured and sterilised in accordance with the applicable specifications.The mhrs for the tibial and femoral components could not be retrieved because their details were not available at the time of writing of this assessment.A review of the complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 159554.No trends were identified with respect to similar complaint.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to dislocation.In the risk file, dislocation is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 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 (surgical intervention) is considered to be within the severity of the rmf.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 the patient underwent a revision surgery due to dislocation of the mobile bearing of his oxford implant.

• Brand Name: OXF ANAT BRG LT LG SIZE 3 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: 10859133
• MDR Text Key: 216844839
• Report Number: 3002806535-2020-00485
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786008
• UDI-Public: 05019279786008
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Model Number: N/A
• Device Catalogue Number: 159554
• Device Lot Number: 458580
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2020
• 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 Age: 54 YR
• Patient Weight: 112