MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM SM PMA; OXFORD PARTIAL KNEE SYSTEM

Model Number N/A

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

Patient Problem No Information (3190)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: oxf uni tib tray sz b rm pma, catalog #: 154721, lot #: 814440.Medical product: oxf twin-peg cmntd fem sm pma, catalog #: 159568, lot #: 747910.Medical product: oxf sawblade stryker cmntd 3pk, catalog #: 506298, lot #: 273997.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00313, 3002806535-2020-00315.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00313-1, 3002806535-2020-00315-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.One anteroposterior radiograph was provided with (b)(4).Email communication informed that the radiograph was taken on (b)(6) 2020, 3 months before the revision date reported in the complaint description.Immediate post-primary surgery radiographs were not provided and are required for the assessment of the initial fit and positioning of components.On the provided radiograph, the medial edge of the tibial tray appears to be short of the medial edge of the tibial plateau.The oxford surgical technique recommends the medial edge of the tibial tray to be flush with or to have less than 2 mm overhang from the medial edge of the tibial plateau.The cement mantle below the tibial tray appears uneven, and both the tibial tray and the femoral component appear to be positioned at an angle.More specifically, the tibial tray appears to be positioned in varus, and the femoral component in valgus, although a full tibia radiograph would be required to confirm this.The oxford surgical technique recommends the tibial tray to be positioned with less than 5 degrees of either varus or valgus inclination with respect to the central axis of the tibia, and the femoral component to be positioned with less than 10 degrees of either varus or valgus inclination with respect to the horizontal axis of the tibial tray.The x-ray marker wire and balls from the oxford meniscal bearing indicate that the bearing is positioned centrally and is parallel with the tibial component, as recommended in the oxford surgical technique.The fit and positioning of components cannot be fully discussed without mediolateral radiographs being provided.The zimmer biomet product experience report (zper) informs that the patient is female, was 48 at the time of the primary surgery reported in the complaint description, is 66 (1.68 m) tall and weighs 164 lb (74 kg), therefore her bmi is 26.2 (overweight).Email communication informs that there were no contributing conditions to the revision, that components will not be returned for evaluation and that the surgical technique was followed, but no other information is available.The instructions for use document included with the components provided the following information: warnings: -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.-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.The manufacturing history records (mhrs) of all components have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications.The sub-optimal cementing technique, fit and positioning of components may have been contributing factors to the reported revision.However, additional radiographic (post-primary and immediate pre-revision x-rays) and surgical information is required to confirm the root cause of the reported revision, as well as provision of the explanted components for examination.These have been requested but it was reported by the sales representative that no further information is available for (b)(4).Risk assessment: -the reason for the revision has not been reported, and on evaluation of the x-rays provided the root cause of the reported event could not be determined.Therefore, no assessment of the outcome of this event could be conducted with the information currently provided.-if further information is provided regarding the root cause of the reported event then risk should be reassessed.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 a patient underwent an initial knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.

• Brand Name: OXF TWIN-PEG CMNTD FEM SM PMA
• 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: 10262883
• MDR Text Key: 198507528
• Report Number: 3002806535-2020-00314
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438228
• UDI-Public: 05019279438228
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 161468
• Device Lot Number: 737300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 09/02/2020
• Supplement Dates FDA Received: 09/10/2020
• 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 Weight: 74