MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Upon opening the sterile packaging of ceramic heads, it was reported that the foam packaging stuck to the tyvek lid.This device was used on this surgery.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in japan.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints database over the last 3 years has found no similar complaints for this item code.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: relevant line: - 5.1.2 ¿ customer cannot deliver product into the sterile field in a controlled manor.The severity score associated with this failure mode is 2 (temporary or reversible impairment (without medical intervention)) with an occurrence score of 1 (<1 in 10000).Severity assessment: -this event occurred during surgery.No further information has been provided/no harm was reported/a non-clinically significant delay (<30mins) to surgery was reported.-the severity score is in line with the risk file.Corrective and preventive actions taken: ca-03419/ ie-11839 has been raised to investigate this issue.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product remains implanted.

Event Description

Upon opening the sterile packaging of ceramic heads, it was reported that the foam packaging stuck to the tyvek lid.This device was used on this surgery.No patient, user, or other stakeholder harm.

• Brand Name: DELTA CER FEM HD 32/+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: 10086611
• MDR Text Key: 198757152
• Report Number: 3002806535-2020-00260
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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: 650-1161
• Device Lot Number: 2019020660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1