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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Muscle Weakness (1967); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Joint Dislocation (2374); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: oxf twin-peg cmntd fem sm pma item# 161468; lot# 265800.Oxf uni tib tray sz d rm pma item# 154725; lot# 942050.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.

Event Description

It was reported that approximately four years after initial right partial knee surgery, the patient underwent a conversion to a total knee arthroplasty due to poly dislocation, pain, limited range of motion, swelling, clunking noise when getting out of bed, instability of the polyethylene, radiographic evidence of mobile bearing posterior knee with collapse of the medial compartment with metal-on-metal.During the revision, extensive scaring was noted, the poly was found dislocated posteriorly, and all components were revised without complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.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.Device is used for treatment.Medical records were provided and reviewed by a health care professional.Instability of the polyethylene bearing and arthritic changes in the lateral and patellofemoral compartments, extensive scarring and the polyethylene bearing was dislocated posteriorly.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 Description

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

• Brand Name: OXF ANAT BRG RT SM SIZE 3 PMA
• Type of Device: 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: 16608272
• MDR Text Key: 311925722
• Report Number: 3002806535-2023-00080
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786145
• UDI-Public: (01)05019279786145(17)230426(10)055780
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/26/2023
• Device Model Number: N/A
• Device Catalogue Number: 159568
• Device Lot Number: 055780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 91 KG