MAUDE Adverse Event Report: BIOMET UK LTD. OXF TWIN-PEG CMNTD FEM LG PMA; OXFORD CEMENTED FEMORALS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteopenia/ Osteoporosis (2651)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the patient underwent a left partial knee arthroplasty and approximately 5 years later a revision surgery was performed due to pain.Contributing factor was disease progression.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical device: oxf uni tib tray sz d lm pma; item# 154724; lot# 478380, oxf anat brg lt lg size 3 pma; item# 159554; lot# 561070.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00057, 3002806535 - 2023 - 00058.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 following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: four views of the left knee demonstrate tricompartment osteophytosis and medial compartment narrowing.Spurring of the tibial spines.Patellar osteophytosis.No fracture.Three views of the left knee demonstrate interval medial compartment hemi arthroplasty involving the left knee with no radiolucency.No fracture.Small to moderate joint effusion.Single ap film of the left knee demonstrates persistent medial compartment hemi-arthroplasty with possible subsidence of the component medially along with cortical irregularity of the proximal tibial metaphysis medially in this region.Worsening lateral compartment narrowing also seen.Osteopenia.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 TWIN-PEG CMNTD FEM LG PMA
• Common Device Name: OXFORD CEMENTED FEMORALS
• 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: 16484013
• Report Number: 3002806535-2023-00056
• Device Sequence Number: 20522693
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: (01)05019279438259(17)271013(10)372730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P010014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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
• Report Date (Section B): 03/17/2023

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: 161470
• Device Lot Number: 372730
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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: Male
• Patient Weight: 98 KG