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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2020

Event Type  malfunction  

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, as it remains implanted.Postal code: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that there is a potential of a wrong labelled implant which had been used on a patient.X-rays were reviewed by the surgeon, and he believes that the final construct is longer than he had trialed and mentioned feeling as thought the final implant was tight at the time of implantation.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4).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.Product remains implanted.The reported event has been determined to be a coob.The event reports a product mix up (the label does not match the device).This was not identified following surgery.No harm has been reported, however, the incorrect implant has been implanted.Only a photograph of the label has been provided, however, visual inspection of the photographs provided through another complaint ((b)(4)) confirm a commingle has occurred.Ph-2020-00034 has been raised to hold product affected by the issue.Issue evaluation ie-11715 has been raised to further investigate the issue.Health hazard evaluation (determination) hhed-2020-0082 was raised which was escalated to hhe-2020-0040.A review of manufacturing history records do not show any abnormalities or deviations.A review of complaint history search for past 3 years has found 11 similar complaint with same item, including this complaint ((b)(4)).Risk assessment: risk assessment has been conducted as part of the investigation undertaken in hhe-2020-00040 which has resulted in a field safety corrective action being initiated due to a confirmed manufacturing comingle at zb valencia.Risk assessment summary: pfmea #13 boxing and labeling rev.2 consulted and potential failure mode incorrect inserts selected: potential effect(s) of failure: insert not match with part/customer complaint.Potential causes: operator obtain incorrect material.Severity: 4 critical.No further action needed on this complaint - the fsca will remove product from the field and no need to re-open complaint for further investigation on return of the product.Corrective action taken: issue evaluation ie-11715 has been raised to further investigate the issue.Preventive action taken: issue evaluation ie-11715 has been raised to further investigate the issue.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that there is a potential of a wrong labelled implant which had been used on a patient.X-rays were reviewed by the surgeon, and he believes that the final construct is longer than he had trialled and mentioned feeling as thought the final implant was tight at the time of implantation.No delay of the procedure was reported.Not known impact or consequences to the patient or the user.

• 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: 9863710
• MDR Text Key: 199235551
• Report Number: 3002806535-2020-00179
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2020
• 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: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1