MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; OXFORD UNCEMENTED KNEE SYSTEM INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an initial knee arthroplasty, the posterior part of the instrument broke off and was retained in the patient.A post-operative x-ray confirmed the presence of a small metal thread.However, it was reported that this incident did not cause any harm to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: item#:154926; lot#:7406233; item name: oxford ph3 cementless fem sz m.Item#:166576; lot#: 7290104; item name: oxf uni cmntls tib sz d lm.Item#: 159547; lot#: 7476363; item name: oxf anat brg lt md size 3 pma.G2- norway.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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 and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h10.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.The device is used for treatment.Radiographs were provided and reviewed by a radiologist.Fractured impactor fragment along the posterior margin of the tibial implant as noted, implant fit and alignment are maintained.Bone quality is osteopenic.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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The product has been returned and visually assessed, which confirmed that part of the tab at the end of the inserter has fractured off.The broken off piece was not returned.The inserter shows signs of use with scratches and scuffing on the body of the device.There are also some scratches on the blue tabs and gouging on the back of the inserter.The inserter has a potential field life of 8 years and 6 months.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.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: OXF CMNTLS IMPLANT INSERT
• Common Device Name: OXFORD UNCEMENTED KNEE SYSTEM INSTRUMENTS
• 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: 17070038
• Report Number: 3002806535-2023-00182
• Device Sequence Number: 20304782
• Product Code: LXH
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)141106(10)ZB140802
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 06/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422097
• Device Lot Number: ZB140802
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 06/12/2024
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/14/2023; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2014
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose