MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.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.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical devices: medical product: oxf uni cmntls tib sz a rm, catalog: 166846, lot: 3534505; medical product: oxford ph3 cementless fem sz s, catalog: 154925, lot: 6816531.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00288, 3002806535-2021-00289.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 on (b)(6) 2021.Subsequently, the patient suffered a periprosthetic fracture of the tibia on (b)(6) 2021.Revision surgery was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the r&d for investigation.It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2021.Subsequently, the patient suffered a periprosthetic fracture of the tibia on (b)(6), 2021.Revision surgery is planned as patient currently cannot walk.Revision surgery was performed on (b)(6) 2021.Implant examination: the oxford femoral component item (b)(4): longitudinal wear marks in the direction of articulation were observed on the anterior and middle region of the received femoral component.A wear patch where the longitudinal wear marks are more evident was also observed, which may have occurred due to articulation against third body particles.Some transversal scratches, were found on the bearing surface of the femoral component, likely caused by instruments used during revision or due to articulation of the femoral component against the tibial tray after the tibial fracture occurred.Patches of a white residue, possibly the remainder of the hydroxyapatite (ha) coating or signs of initial bone integration, were observed on the porous coated surface of the received femoral component.The oxford tibial tray item (b)(4): the bearing surface of the received tibial tray presented numerous linear scratches in the direction of articulation, in particular in the middle and posterior region, as well as some indentations on the anterior region of the surface.A wear patch is evident with longitudinal scratches that appeared darker on the surface.The porous coated surface of the received tibial tray, presented some white residue and some areas with a grey residue, possibly the remainder of the hydroxyapatite (ha) coating or signs of initial bone integration.The oxford meniscal bearing item (b)(4): the meniscal bearing was received in overall good condition.The superior articulating surface, presented very light linear marks between the anterior medial corner and the posterior lateral corner, th e inferior articulating surface, was in overall good condition and presented only a few small scratches and an indentation, possibly caused by instruments used during revision.Implant measurement: the meniscal bearing received with (b)(4) was measured with a digital calliper (instrument no.(b)(4)) in comparison to the nominal dimensions in the relevant engineering drawing.All relevant dimensions were above the allowed engineering tolerance thus suggesting that the received bearing may have been autoclaved by the hospital before it was returned to zimmer biomet, as it has been reported in the literature that autoclaving of oxford meniscal bearings alters their dimensions.An oxford partial knee system was revised due to tibial periprosthetic fracture after approximately 3 months in service.The received metal components presented numerous scratches, likely caused by articulation against bone debris and possibly metal-on-metal contact after the tibial fracture occurred.The received meniscal bearing was in overall good condition.The provided post-primary anteroposterior radiograph suggests that a sub-optimal size for the tibial tray may have been selected, although better quality radiographs and mediolateral radiographs are required to confirm this.It is not possible to determine the root cause of the tibial periprosthetic fracture in this instance without provision of additional patient, radiographic and surgical information.However, it has been reported that sub-optimal tibial component sizing and sub-optimal tibial plateau preparation may contribute to tibial periprosthetic fractures in oxford cementless systems.A review of the complaints database shows that we have received no reported events for tibial fracture for the same item numbers prior to the reported event.The severity of the reported event for similar complaints are in line with the risk file.The overall score is moderate risk.Capa: no corrective or preventive action required at this time.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00288-1.3002806535-2021-00289-1.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2021.Subsequently, the patient suffered a periprosthetic fracture of the tibia on (b)(6), 2021.Revision surgery was performed on (b)(6) 2021.

• Brand Name: OXF ANAT BRG RT SM SIZE 4 PMA
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12106468
• MDR Text Key: 259601543
• Report Number: 3002806535-2021-00290
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786162
• UDI-Public: (01)05019279786162(17)241013(10)6653889
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: 159569
• Device Lot Number: 6653889
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention