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

Catalog Number	166574
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
Event or Problem Description
It was reported that approximately six months ago, the patient underwent an initial left cementless medial unicondylar knee arthroplasty.Subsequently, the patient experienced a postoperative tibial fracture.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4) d10 - associated medical devices: oxford uni twin-peg femoral md; item# 166942; lot# j6857086 oxf anat brg lt md size 5 pma; item# 159549; lot# 7456201 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.
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.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 the two views of the left knee labelled immediate postop demonstrates a medial compartment hemiarthroplasty with appropriate positioning.Surgical skin staples,.Air and fluid within the joint space and surrounding soft tissues are consistent with recent surgery.There is mild osteopenia.Two views of the left knee labelled fracture demonstrate an obliquely oriented fracture involving the tibial peg extending infero-medially with associated subsidence of the tibial component as a result.Mild osteopenia is present.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: OXFORD UNI CMNTLS TIB SZ C 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: 19474710
• Report Number: 3002806535-2024-00207
• Device Sequence Number: 3981769
• Product Code: NRA
• UDI-Device Identifier: 00887868354731
• UDI-Public: (01)00887868354731(17)321001(10)7336069
• 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
• Report Date (Section B): 08/01/2024

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: 166574
• Device Lot Number: 7336069
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose