MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD CEMENTLESS TIBIA C RM; OXFORD CEMENTLESS TIBIAL TRAYS

Model Number N/A

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00445, 3002806535-2021-00446.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Remains implanted.

Event Description

It was reported that the patient was seen in clinic on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4).Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed nsaids and will be seen for a follow-up on (b)(6) 2021.

Event Description

It was reported, that: patient was seen in clinic on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4).Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed nsaids and will be seen for a follow-up on (b)(6) 2021.Addi (b)(6) 2021: please see attached the radiographs available prior to the 5 year visit.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: no product was returned; visual and dimensional evaluations could not be performed.This device is used for treatment.No compatibility issues were noted.Device history record (dhr) review was unable to be performed as item #161474, lot #2409869 is missing and listed in capa ca-03772 missing mhrs.Review of the device history records for item #159575, lot #533550 and item #us166575, lot #3050471 identified no related deviations or anomalies during manufacturing related to the reported event.A review of the complaints database for 3 years prior to the notification date has identified the following: (6) similar complaints for item #159575 (including initiating complaint).There were (0) additional complaints against the lot #533550.(2) similar complaints for item #161474 (including initiating complaint).There were (0) additional complaints against the lot #2409869.(1) similar complaints for item #us166575 (including initiating complaint).There were (0) additional complaints against the lot #3050471.The clinical study patient was seen on (b)(6) 2021 complaining of pain on her right pes anserinus bursa site.This issue was first noted on (b)(6) 2019 and was reported in (b)(4): in the radiographs from the 5-year follow-up the fit and position of all components appear to be adequate in accordance with the guidelines in the oxford surgical technique.Per visit note from (b)(6) 2021, implant is in good position, there were no evidence of fracture/lysis/wear/subsidence.Patient was prescribed treatment.The root cause of the reported adverse event could not be determined with the available information.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and further investigated.Multiple mdr reports were filed for this event, please see associated report numbers: 3002806535-2021-00445-1, 3002806535-2021-00446-1.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.

• Brand Name: OXFORD CEMENTLESS TIBIA C RM
• Type of Device: OXFORD CEMENTLESS TIBIAL TRAYS
• 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: 12638099
• MDR Text Key: 276558470
• Report Number: 3002806535-2021-00447
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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: 06/26/2023
• Device Model Number: N/A
• Device Catalogue Number: US166575
• Device Lot Number: 3050471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2013
• 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): Other
• Patient Age: 76 YR
• Patient Weight: 76 KG