MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNCEMENTED TIBIAL IMPACTOR; NON MODULAR TIBIAL TRAY IMPACTOR (CEMENTLESS APPLICATION)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source- (b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that upon completion of the knee arthroplasty, post operative x-rays showed a fragment of the implant inserter was retained in the patient.No health impact to the patient has been reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record identified no deviations or anomalies during manufacturing.The device is used for treatment.Radiographs were provided and reviewed by a healthcare professional.A review of the available records identified the following: thin linear increased density transversely oriented structure distal to the articular surface of the medial compartment hardware, likely corresponding to the cementless tibia inserter described on the event/deficiency description.A definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified item/lot information match what is listed in the sub form of the complaint.Device shows signs of repeated use with nicks, gouges and scratches throughout the device.The tip has fractured and not all pieces have been returned.There is also a screw that has came out of the inserter.Fracture analysis is inconclusive, fracture surface artifacts of rivers lines and an apparent bending hinge suggest the bending overload failure mode.With the available information, a definitive root cause cannot be determined.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 UNCEMENTED TIBIAL IMPACTOR
• Common Device Name: NON MODULAR TIBIAL TRAY IMPACTOR (CEMENTLESS APPLICATION)
• 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: 16144640
• Report Number: 3002806535-2023-00016
• Device Sequence Number: 20304832
• Product Code: MDM
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)170228(10)ZB160804
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/05/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB160804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 02/21/2023; 05/31/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/17/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 85 KG