MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM MD PMA; KNEE PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Noise, Audible (3273); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately year after partial left knee arthroplasty patient experienced cracking, popping and pain.Bone scan showed loosening.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products: item reference: unknown, item name: unknown oxford bearing left, item lot: unknown item reference: unknown, item name: unknown oxford tibial component left, item lot: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00144 and 3002806535-2023-00146.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.H3 other text: product data and product not available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: a4, b3, b4, b5, b7, d1, d2, d4, d5, d9, d10, g1, g3, g4, g6, h1, h2, h3, h4, h6, h10.D10: associated products: item number: 159548, item name: oxf anat brg lt md size 4 pma, item lot: unknown, item number: 154724, item name: oxf uni tib tray sz d lm pma, item lot: 301410.
Event or Problem Description
It was reported that approximately two (2) years after initial bilateral partial knee replacements the patient presented with pain and stiffness in bilateral knees, right greater than left.Bone scans revealed mild reuptake in the left knee.As complaints are greater for the right side, no further intervention is planned for the left side at this time.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).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d9, d10, g1, g3, g6, h1, h2, h3, h6, h10.D10: associated products: item number: 159548, item name: oxf anat brg lt md size 4 pma, item lot: 274230.Item number: 110035368, item name: biomet bc r 1x40 us, item lot: h2203z36ba.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 that could be related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a radiologist.The earlier images demonstrate bilateral medial unicompartmental arthroplasties with anatomic alignment.Subsequent images 19 months post implantation demonstrate new radiolucency at the medial margin of the right knee tibial implant bone-metal interface consistent with osteolysis and early implant loosening.Overall alignment is maintained.The left knee appears unchanged.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.

• Brand Name: OXF TWIN-PEG CMNTD FEM MD 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: 16960674
• Report Number: 3002806535-2023-00145
• Device Sequence Number: 5224889
• Product Code: NRA
• UDI-Device Identifier: 05019279438242
• UDI-Public: (01)05019279438242(17)310322(10)255200
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2023

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: 161469
• Device Lot Number: 255200
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 05/17/2023; 06/16/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/14/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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; SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 107 KG