MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI CMNTLS TIB SZ B LM; KNEE PROSTHESIS

Catalog Number	166572
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10 - associated medical devices: unknown oxford femoral component; item# unknown; lot# unknown.Unknown oxford bearing; item# unknown; lot# unknown.G2 - foreign: the netherlands.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient experienced a tibial bone fracture after implantation of oxford knee prosthesis.It was mentioned that competitor keel blades were used to prep the bone during initial implantation.The tibia was plated, no implant revised.Due diligence is in progress for this complaint; no further additional information or product has been received.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated.D10 - associated medical devices: oxford ph3 cementless fem sz m; item# 154926; lot# 7411619 oxf anat brg lt md size 3 pma; item# 159547; lot# 7428861 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 or Problem Description
It was reported that approximately eleven months ago, the patient underwent an initial left cementless medial unicondylar knee arthroplasty.Subsequently, the patient was revised on an unknown date due to tibial fracture.No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.A review for compatibility of the reported de soutter manufactured blades used in the surgery identified that these blades are not validated for the use with zimmer biomet oxford cementless implants and guides.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process.Initial op notes were provided and reviewed by a health care professional however information was limited.There were no intraoperative complications identified.Radiographs were provided and reviewed by a radiologist.The review identified that two views of the left knee labelled immediate postop and fracture demonstrate a medial compartment hemiarthroplasty without definite evidence for malposition.Surgical skin staples are seen.Fracture images demonstrate a vertically oriented fracture along the tibial peg extending inferiorly.Cortical irregularity also seen along the medial aspect of the distal femoral metaphysis which was present on the prior study but has worsened.No contribute factors seen involving the proximal tibia fracture.With the available information a definitive root cause cannot be determined however, it is not clear that the de soutter blades allow for an adequate keel cut in all dimensions: width, length, and depth.Zimmer biomet offers blades specifically designed to be used with oxford cementless partial knee implants, and the dimensions of the blades and templates are aligned for the appropriate clearances and tolerances.The use of the de soutter blades may therefore be contributory to the reported tibial bone fracture.Zimmer biomet legal dept have issued notice on de soutter regarding this reported event demanding that de soutter cease promoting their keel saw blade system for the use with zimmer biomet oxford cementless partial knees.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.

• Brand Name: OXFORD UNI CMNTLS TIB SZ B LM
• Common Device Name: KNEE PROSTHESIS
• 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: 19069396
• Report Number: 3002806535-2024-00135
• Device Sequence Number: 6900728
• Product Code: NRA
• UDI-Device Identifier: 00887868354717
• UDI-Public: (01)00887868354717(17)321008(10)7339530
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 166572
• Device Lot Number: 7339530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 08/01/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/06/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose