MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZA LM; OXFORD CEMENTED TIBIAL TRAYS

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 09/22/2021

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 is contaminated.Concomitant medical products: medical product: oxf twin-peg cmntd fem sm pma, catalog no.: 161468, lot no.: unknown.Multiple mdr reports were filed for this event, associated reports: 3002806535-2021-00429.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that oxford mobile bearing implants were revised to a vanguard total knee.The tibial tray implant appeared to be loose when taking the parts out.Patient involved.

Manufacturer Narrative

(b)(4).Complaint summary: adequate photographs have not been provided and product has not been returned for evaluation.Therefore, the investigation has been limited to the information provided, patient x-rays and a complaint history search.Review of the device history records could not be carried out as the lot.Numbers are unknown.Review of complaint history identified 2 similar complaints for the reported item 154718 and no additional complaints for the reported item 159540 (lot search not completed as lot numbers are unknown).These devices are used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.As the lot numbers are unknown it cannot not be confirmed that the implants have not been within the scope or subject of any field actions or recalls which could be attributed to reported event.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided, products have not been returned for evaluation.The root cause of the reported event cannot be determined with the information provided.The primary reason for the reported loosening of the tibial tray could not be determined without provision of immediate post-primary radiographs, additional patient information (such as activity level, bone quality), primary and revision surgery notes, and without examination of the revised components, however the presence of third body debris in the joint space and suboptimal position of the tibial tray may be contributing factors.Corrective or preventative action not required.The root cause of the reported event cannot be determined with the information provided.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00429-1.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.H3 other text : device not returned due to contamination.

Event Description

It was reported that oxford mobile bearing implants were revised to a vanguard total knee.The tibial tray implant appeared to be loose when taking the parts out.Patient involved.

• Brand Name: OXF UNI TIB TRAY SZA LM
• Type of Device: OXFORD CEMENTED 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: 12559744
• MDR Text Key: 274231751
• Report Number: 3002806535-2021-00428
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279388844
• UDI-Public: 05019279388844
• 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: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 154718
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female