MAUDE Adverse Event Report: BIOMET UK LTD. TINBN COATED OXF FEM SM/UK; KNEE PROSTHESIS

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Local Reaction (2035)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Concomitant medical products: tinbn coated oxf tib tray a rm, catalog #:154719tnbn, lot #: not reported; oxf anat brg rt sm size 6 pma, catalog #:159571, lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00399, 3002806535-2019-00400.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to tibial loosening was carried out.During the procedure, the surgeon also discovered discoloration of the intra-articular soft tissue.

Event Description

It was reported by the hospital that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to tibial loosening was carried out.During the procedure, the surgeon also discovered discoloration of the intra-articular soft tissue.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).Two radiographs were provided.The date on which these radiographs were taken is not known.Post-primary radiographs are required in order to assess the initial component size, position and alignment.On the medio-lateral radiograph, the femoral component appears to be sized and positioned correctly.A radiolucent line is visible anteriorly below the tibial tray.On the antero-posterior radiograph, the femoral component appears to be sized and positioned correctly.The x-ray marker balls and wire indicate that the meniscal bearing was positioned centrally between the femoral and tibial components, and was parallel with the tibial tray, as recommended in the oxford surgical technique.A gap is evident between the bone and the tibial tray around the keel and at the vertical wall.The cement mantle also appears to be uneven around the tibial tray.A large third-body fragment is visible medially in the joint space, which is likely to be a fragment of bone or bone cement.The ¿discoloration (gold) of the whole intra-articular soft tissue¿ described by the surgeon suggests that some of the tinbn coating may have been removed, although without examination of the components, it would not be possible to determine the root cause of this.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported by the hospital that a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to tibial loosening was carried out.During the procedure, the surgeon also discovered discoloration of the intra-articular soft tissue.

• Brand Name: TINBN COATED OXF FEM SM/UK
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8542985
• MDR Text Key: 142868536
• Report Number: 3002806535-2019-00398
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154600TNBN
• Device Lot Number: 3804688
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• 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