MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 5 PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent knee revision due to the poly wear and instability in unknown timeframe after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).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 and/or corrected information.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 patient underwent left knee revision due to the poly wear and instability about eight (8) years after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a4, b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10.Visual examination of the provided pictures identified wear and discoloration on the spherical bearing face, there appears to be burrs (displaced material) on the bottom flat bearing surface but this is unclear as there are no photographs of the bottom bearing surface.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Medical records were not provided.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.
Additional Manufacturer Narrative
Product has returned.Visual examination of the returned product identified scuffs and indentations / pitting to the articulation surface and other scuffs and indentations to other surfaces.This is evident in particular to the bottom flat bearing surface which exhibits what appears to be gouging of the material resulting in burrs.It is not clear on how these indentations, scuffs and gouges may have been caused with the information provided however it may indicate the presence of a third body or may have been caused by the instruments when being removed.Additionally, there are possible indications of mal tracking as the lot number is not fully readable which could indicate tracking against the lateral wall of the tray.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 ANAT BRG LT MD SIZE 5 PMA
• 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: 17332377
• Report Number: 3002806535-2023-00247
• Device Sequence Number: 6608075
• Product Code: NRA
• UDI-Device Identifier: 05019279785957
• UDI-Public: (01)05019279785957
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 11/30/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 159549
• Device Lot Number: UNKNOWN
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 09/05/2023; 11/29/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/07/2023; 09/06/2023; 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 81 KG