MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT SM SIZE 3 PMA; PROSTHESIS, KNEE

Catalog Number	159568
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 the patient underwent revision surgery due to dislocation.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Event or Problem Description
It was reported that the patient underwent revision surgery due to dislocation of the bearing and pain.
Additional Manufacturer Narrative
(b)(4).D10.Item#:unknown ;lot#: unknown ;item name: unknown femoral component ; item#:unknown ;lot#: unknown ;item name: unknown tibial component; this follow-up report is being submitted to relay additional information.Investigation of this incident is currently ongoing.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.Visual examination of the returned product identified that the spherical surface has some wear, dents and marks but is otherwise in good condition.A review of the device manufacturing records confirmed no abnormalities or deviations.Devices are used for treatment.Medical records were provided and reviewed by a health care professional.The review identified initial right partial knee replacement was performed, and subsequently the patient was revised two years and four months later due to anterior dislocation of the poly.During the revision components were found to have clean surfaces without defect, the poly was revised without complications.With the available information, a definitive root cause could not 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 ANAT BRG RT SM SIZE 3 PMA
• Common Device Name: PROSTHESIS, KNEE
• 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: 18073034
• Report Number: 3002806535-2023-00373
• Device Sequence Number: 7815644
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: (01)05019279786145(17)260402(10)410100
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2024

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: Lay User/Patient
• Device Expiration Date: 04/02/2026
• Device Catalogue Number: 159568
• Device Lot Number: 410100
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 01/05/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/13/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Female