MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS FEMORAL COCR SMALL; UNKNOWN

Catalog Number 154600

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported by the hospital that a patient was undergoing a right uni-compartmental knee replacement and the team opened a sealed boxed 154600 (femoral cocr small) but inside the boxed was a sealed 154722 (left cocr lm std).

Manufacturer Narrative

(b)(4).Device history record (dhr) was reviewed and no discrepancies were found.The reported event has not been confirmed as it is likely that the mix up occurred at point of use.We can confirm that the products listed above were manufactured at different locations negating a commingle at manufacturing process.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event is user error.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.

Event Description

It has been reported by the hospital that during surgery a sealed product was opened and the wrong product was inside.Subsequently, the surgery was completed with a back-up same size implant.

• Brand Name: OXFORD PKS FEMORAL COCR SMALL
• Type of Device: UNKNOWN
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8031978
• MDR Text Key: 126074293
• Report Number: 3002806535-2018-01183
• Device Sequence Number: 1
• Product Code: NRA
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 154600
• Device Lot Number: J3707269
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1