MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; OXFORD HXLPE BEARINGS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 01/17/2022

Event Type  Injury  

Event Description

It was reported, that: planned replacement surgery of the left knee joint with intraoperative evidence of an inlay fracture.Bfarm case number: (b)(4).Patient outcome: serious injury.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The device is currently implanted within the patient, but is scheduled for removal in revision surgery.At this time it is unknown whether the device will return for investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Event Description

It was reported, that: planned replacement surgery of the left knee joint with intraoperative evidence of an inlay fracture.(b)(6) case number: (b)(4).Patient outcome: serious injury.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The device is currently implanted within the patient, but is scheduled for removal in revision surgery.At this time it is unknown whether the device will return for investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d6, d10, g3, g6, h1, h2, h10.Implant and revision dates have been provided.Associate products: medical product: oxf uni tib tray sz f lm pma, catalog #: 154775, lot #: 2228379 medical product: oxf anat brg lt lg size 4 pma, catalog #:159555, lot #:2052745 the investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to oxford bearing fracture was performed on (b)(6)2022.Surgical indication was lateral connection arthrosis, inlay fracture was more or less an intraoperative additional diagnosis.Inlay wear is assumed to be the cause of the fracture.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.X-rays or medical notes have not been provided.This device is used for treatment.No compatibility issues were noted.A review of complaint history was assessed for three years prior to the notification date and identified (3) similar complaints for item #159555 (including initiating complaint).There were (0) additional complaints against the lot #2052745.It has been confirmed that the implant is not within the scope or subject of any capa, field actions or recalls which could be attributed to reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : product not returned.

Event Description

It was reported that a patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to oxford bearing fracture was performed approximately 9 months later.Surgical indication was lateral connection arthrosis, inlay fracture was more or less an intraoperative additional diagnosis.Inlay wear is assumed to be the cause of the fracture.Attempts have been made but no further information has been provided at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Product was returned.Visual examination will be performed.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The component was received split in two fragments, both presenting extensive wear, material loss and whitening/oxidation.The thickness of the central region was found to have reduced during service to 1.74 mm, indicating a wear rate of approximately 0.25 mm/year on average.Review of the device history record identified no deviations or anomalies during manufacturing.It is not possible to confirm the exact root cause of the excessive wear and fracture of the oxford bearing in this instance.However, the cementing technique, the alignment of components, and the progression of arthrosis in the lateral compartment of the patient¿s knee may have caused abnormal loads to be transferred to the polyethylene component, thus contributing to its failure.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: OXF ANAT BRG LT LG SIZE 4 PMA
• Type of Device: OXFORD HXLPE BEARINGS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13576547
• MDR Text Key: 285931624
• Report Number: 3002806535-2022-00074
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786015
• UDI-Public: (01)05019279786015(17)150527(10)2052745
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2015
• Device Model Number: N/A
• Device Catalogue Number: 159555
• Device Lot Number: 2052745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 COMMENTS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male