MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 CEMENTLESS FEM SZ S; KNEE PROTHESIS

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report: unique identifier (udi) number: (b)(4).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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

When unboxing a oxford femur implant, layer two was divided in half when staff peeled off sterility box.The staff could not guarantee sterility so they retrieved a new implant.No impact on the patient.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.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 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 complaint database over the last 3 years has found no similar complaints reported with the item and lot combination.A review of the complaint database over the last 3 years has found 1 similar complaint reported with the item 154925.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: -this event occurred during surgery.No further information has been provided.-this gives a severity score of 2.-the severity score is in line with the risk file.Occurrence assessment: - the occurrence rate has been calculated as detailed in the n hhe-020-00071.-the occurrence rate of the reported event is (b)(4)%, however, with an occurrence rate of harm (which is a non-clinically significant extension to surgery time) is (b)(4)%.This is in line with the risk file.-risk score: s2 x o1 ¿ rpn 2 (negligible) -the severity of the reported event and the calculated occurrence is in line with this risk file.-the overall risk score is negligible.Corrective and preventive actions, field actions: - issue evaluation ie-11483 has been raised to further investigate similar reported events.- scar-02737 has been raised to document any corrective and preventative actions made by the supplier.-health hazard evaluation hhe-2020-00071 has been raised to assess the risk of product which may exhibit the issue in the field.This hhe resulted in a no field safety corrective action decision.-this complaint is within the scope of this hhe.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product has not been returned.

Event Description

It was reported that when unboxing a oxford femur implant, layer two was divided in half when staff peeled off sterility box.The staff could not guarantee sterility of the implant, therefore, they retrieved a new implant.No impact on the patient.

• Brand Name: OXFORD PH3 CEMENTLESS FEM SZ S
• Type of Device: KNEE PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10498951
• MDR Text Key: 206880195
• Report Number: 3002806535-2020-00410
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• 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: 154925
• Device Lot Number: 6627274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other