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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteopenia/ Osteoporosis (2651)

Event Date 02/06/2023

Event Type  Injury  

Event 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.

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.

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 Description

No further event information available at the time of this report.

• Brand Name: OXF TWIN-PEG CMNTD FEM LG PMA
• Type of Device: 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
• MDR Text Key: 310678898
• Report Number: 3002806535-2023-00056
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279438259
• UDI-Public: (01)05019279438259(17)271013(10)372730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 98 KG