MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ C RM; OXFORD CEMENTLESS TIBIAL TRAYS

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tibial cementless base plate is larger than the actual dimensions indicated on the label, and the cementless base plate with a larger dimension than indicated may have been used, resulting in a series of tibial fractures.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D6 - product remains implanted.D10 - medical devices: oxf anat brg rt sm size 6 pma; item# 159571; lot# 7243251, oxford uni twin-peg femoral sm cocr sml; item# 166941; lot# j7445667.G2 - foreign: japan.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 product remains implanted; therefore, visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Radiographs were provided and reviewed by a radiologist.The review identified initial anatomic alignment of the right knee medial unicompartmental arthroplasty complicated by a periprosthetic fracture of the medial tibia with implant loosening and subsidence.Osteopenia.Initial fit and alignment were maintained.2 month imaging demonstrates tibial implant loosening and subsidence with malalignment secondary to a tibial periprosthetic fracture.Bone quality is osteopenic.The tibial implant is loose with subsidence and malalignment secondary to the periprosthetic fracture as noted.There is a medial tibial periprosthetic fracture.The degree of osteopenia present could contribute to a fracture in this patient.With the available information, a definitive root cause could not be determined however, osteopenia could be a contributing factor.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: OXF UNI CMNTLS TIB SZ C RM
• Common Device Name: OXFORD CEMENTLESS TIBIAL TRAYS
• 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: 17850413
• Report Number: 3002806535-2023-00330
• Device Sequence Number: 17813186
• Product Code: NRA
• UDI-Device Identifier: 00887868354748
• UDI-Public: (01)00887868354748(17)320902(10)7307179
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• 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): 12/11/2023

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 Model Number: N/A
• Device Catalogue Number: 166575
• Device Lot Number: 7307179
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose