MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 28/-3MM T1; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being 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

During thr, it was noticed that the size indicated on the package did not match the size indicated on the implant.Subsequently, a new implant was used and safely implanted.Implant states: +3mm, package states: -3mm.

Event Description

During thr, it was noticed that the size indicated on the package did not match the size indicated on the implant.Subsequently, a new implant was used and safely implanted.Implant states: +3mm.Package states: -3mm.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.The reported event has been determined to be a coob.The event reports that the labelling on the outer box did not match the device.This was identified during surgery and resulted in a 0-15 min extension to surgery time.An alternative device was used to complete the surgery.No photographs of the implant (photographs of the label have been provided) have been provided and no product has been returned, however, visual inspection of the photographs provided through another complaint ((b)(4)) confirm a commingle has occurred.(b)(4) has been raised to hold product affected by the issue.Issue evaluation (b)(4) has been raised to further investigate the issue.Health hazard evaluation (determination) (b)(4) was raised which was escalated to (b)(4).A review of the complaint database over the last 3 years has found 4 similar complaints reported with these items.A review of the manufacturing history records confirms no abnormalities or deviations reported.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product not returned.

• Brand Name: DELTA CER FEM HD 28/-3MM T1
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9778780
• MDR Text Key: 219547820
• Report Number: 3002806535-2020-00105
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K131684
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• 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: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other