MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ M; OXFORD CEMENTLESS FEMORALS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 10/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product will not be returned to zimmer biomet for investigation.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00473, 3002806535-2021-00474.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6) 2017.Subsequently, a revision due to pain was performed on (b)(6) 2021.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00473-1.3002806535-2021-00474-1.Product has not been returned for evaluation, and x-rays or medical notes have not been provided.Therefore, the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.These devices are used for treatment.No compatibility issues were noted.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history was assessed for three years prior to the notification date and identified 3 similar complaints for item 154926.There were no additional complaints against the lot 3981405.A review of complaint history was assessed for three years prior to the notification date and identified 2 similar complaints for item 159549.There were no additional complaints against the lot 3850890.A review of complaint history was assessed for three years prior to the notification date and identified no additional complaints for item 166574.There were no additional complaints against the lot 3831429.These part and lot combinations are not associated with any recalls at the time the search was conducted.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The likely condition of the devices when they left zimmer biomet is conforming to specification.The root cause of the reported event cannot be determined with the information provided if any additional information becomes available, then the complaint will be reopened and further investigated.

Event Description

It was reported that a patient underwent an initial knee arthroplasty on (b)(6), 2017.Subsequently, a revision due to pain was performed on (b)(6), 2021.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ M
• Type of Device: OXFORD CEMENTLESS 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: 12727735
• MDR Text Key: 279324437
• Report Number: 3002806535-2021-00472
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 154926
• Device Lot Number: 3981405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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