MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/-3MM T1; HIP PROTHESIS

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that the size indicated on the label did not match the size indicated on the implant.The surgeon hadn¿t checked if the implant matched the box description in advance.He proceeded to close the patient¿s wound and only noticed the leg-length discrepancy on his final checks.Subsequently, the surgeon opened the wound again and used a implant.It was also noticed at that time that the femur had cracked.

Event Description

It was reported that the size indicated on the label did not match the size indicated on the implant.The surgeon hadn¿t checked if the implant matched the box description in advance.He proceeded to close the patient¿s wound and only noticed the leg-length discrepancy on his final checks.Subsequently, the surgeon opened the wound again and used a new -3mm implant.It was also noticed that the femur had cracked as a consequence of the incorrect head length.There was 2 hours delay.Label states: -3mm implant states: +3mm.

Manufacturer Narrative

This final report is being submitted to relay additional information.The following sections were updated: a2, b4, b5, d10, e1, g4, g7, h1, h2, h3, h6, h10.G3: report source, foreign - event occurred in united kingdom.The product has not been returned to biomet for evaluation, therefore, a thorough investigation has not been possible.The event reports that the labelling on the outer box did not match the device.This was identified during surgery and resulted in the surgical wound being reopened to revise the device, a femur fracture, and a 2 hour extension to surgery time.An alternative device was used to complete the surgery.Photographs provided confirm a commingle has occurred.Corrective actions: ph-2020-00034 has been raised to hold product affected by the issue.This has been investigated and completed (hhe-2020-00040/hhed-2020-0082).A field safety and corrective action has been initiated.Capa has been raised (b)(4).A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints database has found 5 similar complaints for this item code if any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Product has not been returned.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9835865
• MDR Text Key: 199057536
• Report Number: 3002806535-2020-00144
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1159
• Device Lot Number: 2019091307
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR