MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI CMNTLS TIB SZ D LM; OXFORD CEMENTLESS TIBIAL TRAYS

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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 partial left knee arthroplasty on (b)(6), 2021.Subsequently, a revision procedure due to tibia fracture was performed on (b)(6), 2021.Revision surgery was a smith and nephew wrist plate to fix the fracture then a cr nexgen with 100x10mm stem on tibia, performed by mr muller and prof reed.No further outcome.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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, a review of the device history records, and a complaint history search.X-rays have been provided but unfortunately they are taken after the tibial fracture.Post-primary radiographs (i.E.Pre-fracture) are needed in order to assess component size, position and alignment.Oxford pks cementless ifu: states: intraoperative bone perforation or fracture may occur, particularly in the presence of poor bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified 1 additional similar complaint for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the implant is not within the scope or subject of any field actions or recalls which could be attributed to reported event.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as relevant photographs have not been provided and packaging has not been returned for evaluation and the dhr review did not identify any issues.The definitive root cause of this event cannot be determined with the available information.Corrective or preventative action not required.Reported event has not been confirmed as relevant photographs and x-rays have not been provided and product has not been returned for evaluation.No manufacturing, design, or compliance issue has been identified.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 : item not returned.

Event Description

It was reported that a patient underwent an initial partial left knee arthroplasty on (b)(6) 2021.Subsequently, a revision procedure due to tibia fracture was performed on (b)(6) 2021.Revision surgery was a smith and nephew wrist plate to fix the fracture then a cr nexgen with 100x10mm stem on tibia, performed by mr muller and prof reed.No further outcome.

• Brand Name: OXF UNI CMNTLS TIB SZ D LM
• 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: 12850538
• MDR Text Key: 282769160
• Report Number: 3002806535-2021-00504
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• 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: 166576
• Device Lot Number: 6990789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2021
• 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