MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT MD SIZE 4 PMA; KNEE PROSTHESIS

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 02/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Product location is currently unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the patient¿s attorney, that the patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation.The item and lot number have not been provided.X-rays or medical notes have not been provided.The investigation has been limited to the information provided.A historical search could not be performed as the item and lot number have not been provided.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.A dhr review or a review of recalls could not be performed as the item and lot number have not been provided.The likely condition of the device when it left zimmer biomet could not be determined as the item and lot number has not been provided.The root cause of the reported event can not be determined with the information provided no corrective action required at this time as the root cause of the reported event has not been determined.No corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported by the patient¿s attorney, that: the patient underwent an initial right knee arthroplasty on (b)(6) 2017.Subsequently, a revision procedure due to dislocation was performed on (b)(6) 2021.Only oxford bearing revised.Patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d2, d4, d9, g3, g6, h1, h2, h3, h4, h6, h10.Visual examination of the returned product identified that the bearing has damage on articulating surface and severe wear on one edge.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were not provided.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.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Medical records and x-rays were provided radiographs confirmed a displaced medial unicondylar knee athrolplasty polyethylene component with the displacement being into the posterior joint.Radiographs demonstrate no evidence of loosening.Surgical notes state that the surgeon thoroughly evaluated the medial femoral component and the medial tibial component and there was no evidence of loosening.Whilst the operative notes do not identify the final bearing used, the complaint relates to revision of a size 4 right bearing.The surgeon had prepared the knee using a 5 feeler gauge and stated that this feeler gauge fitted comfortably.A size 5 bearing should therefore have been used.Use of a size 4 bearing would result in 1mm of ligamentous laxity compared to a size 5 bearing.This is in addition to the excess 1mm that appears to have been removed when the surgeon milled the distal femur, giving a potential 2mm of ligamentous laxity with the patient¿s leg in extension.This laxity may have allowed the femoral component to ride up on the posterior lip of the bearing as the patient flexed their knee.It is noted that in the operative notes for the first revision procedure, the surgeon used a size 5 bearing.This would indicate that either a) the original bearing was undersized, or b) the patient¿s ligament tension had reduced between the original procedure and the revision procedure.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 ANAT BRG RT MD SIZE 4 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: 12539539
• MDR Text Key: 273540755
• Report Number: 3002806535-2021-00413
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279786220
• UDI-Public: (01)05019279786220(17)220511(10)871800
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 159576
• Device Lot Number: 871800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 12/20/2021; 07/26/2021; 09/17/2022
• Supplement Dates FDA Received: 12/22/2021; 08/24/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White