MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS CEMENTED TIBIA, ALPHA STANDARD, RIGHT MEDIAL SIZE D; KNEE PROSTHESIS

Model Number N/A

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: oxf twin-peg cmntd fem lg pma item#161470 lot#483330.Oxf anat brg rt lg size 4 pma item#159583 lot#418060.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 a patient underwent an initial right knee arthroplasty.Subsequently, a revision procedure due to subsidence was performed, approximately six (6) years post-op.Attempts have been made and no further information has been provided.

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 products were returned.The device history records for item # 154725 lot # 702750 were reviewed for deviations and / or anomalies with no anomalies / deviations identified.The device is used for treatment.Radiographs were provided.Significant findings in mmi report include subsidence of the medial tibial component is present, osteopenia, and right medial compartment hemi-arthroplasty with subsidence of the medial tibial component.The likely condition of the device when it left zimmer biomet is conforming to specification.The definitive root cause of the reported event cannot be determined with the information provided.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: OXFORD PKS CEMENTED TIBIA, ALPHA STANDARD, RIGHT MEDIAL SIZE D
• 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: 14673777
• MDR Text Key: 293827167
• Report Number: 3002806535-2022-00274
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388912
• UDI-Public: (01)05019279388912(17)260715(10)702750
• 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: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• 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: 154725
• Device Lot Number: 702750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• 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: 97 KG