MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 3 PMA SML SZ 3; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.The bearing was revised from 3 to 5 mm.Attempts have been made but no further information has been provided at this time.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.The bearing was revised from 3 to 5 mm.

Manufacturer Narrative

(b)(4).This supplemental report is being submitted to relay additional information.The following sections were updated: a3, b4, b5, g3, h1, h2, h10.Information received: gender: male.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D10:associate products only: medical product: oxf uni tib tray sz c lm pma, catalog #: 154722 lot #: 6449427.Medical product:oxford uni twin-peg femoral sm, catalog #: 166941, lot #: j6441150.The product has not been received, therefore the condition of the components is unknown.A total of thirteen images were provided with cmp-0691501: four pre-primary radiographs; four fluoroscopy images taken during primary surgery on (b)(6) 2020, two anteroposterior (ap) and two mediolateral (ml); three post-primary radiographs, one ap and one ml taken on (b)(6) 2020 and one full-leg ap taken on (b)(6) 2020; one pre-revision ml radiograph taken on (b)(6) 2021; one post-revision ap radiograph taken on (b)(6) 2021.The quality of the provided fluoroscopic images and post-primary radiographs is suboptimal, therefore sizing, fit and positioning of components cannot be verified against the recommendations of the oxford partial knee surgical technique.However, on the provided post-revision radiograph, the medial edge of the tibial tray appears to be short of the medial edge of the tibial plateau.The oxford partial knee surgical technique recommends the medial edge of the tibial tray to be flush with, or to have 2 mm overhang from the medial edge of the tibial plateau.The dislocation of the polyethylene bearing into the posterior joint space is confirmed by the location of the x-ray marker wire and one of the marker balls on the ml radiograph taken on (b)(6) 2021.A darker area surrounding both the tibial tray and the femoral component is visible on the post-revision radiograph, which may indicate lower bone density in the region.However, comparison with earlier radiographs is not possible due to their lower quality.A translation of the provided surgical notes available on etq describes that, during the primary surgery, in 20 degree extension, it appeared that the 3 mm [bearing] could likewise be easily inserted.The oxford partial knee surgical technique recommends to complete the reconstruction by snapping the chosen bearing into place.No patient information was available due to country regulations.The provided translation of the surgical notes reports, as the indication for revision, that the patient had lain down and twisted his left leg.He then experienced severe pain in the knee, with crepitus and restricted movement and a feeling of instability.It is stated in the complaint description, and confirmed in the surgical notes, that the 3mm bearing was revised to a 5mm bearing, thus indicating that some degree of soft tissue laxity may have been present.The instructions for use included with the dislocated polyethylene bearing provided the following information: warnings: 1.Improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.8.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: 2.Biomet joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients.While these devices are generally successful in attaining these goals they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.3.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.Possible adverse effects: 13.Dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.The manufacturing history records (mhrs) of the dislocated oxford bearing and associated components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found 4 complaints reported with the item 159540.It is not possible to confirm the root cause for the bearing dislocation without examination of the revised component.However, sub-optimal component sizing, the patient¿s activity level, bone quality and/or soft tissue laxity may have been contributing factors.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.The bearing was revised from 3 to 5 mm.

• Brand Name: OXF ANAT BRG LT SM SIZE 3 PMA SML SZ 3
• Type of Device: OXFORD PARTIAL KNEE SYSTEM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11812182
• MDR Text Key: 250206701
• Report Number: 3002806535-2021-00188
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 0501927978565
• UDI-Public: (01)0501927978565(17)250113(10)6722374
• Combination Product (y/n): N
• PMA/PMN Number: P01004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• 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: 159540
• Device Lot Number: 6722374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2021
• 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