MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was initially reported the device would not be returned for manufacturer evaluation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It has been reported a hair was found in the inner sterile packaging.No further information has been provided.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Products have been returned to biomet (b)(4) ltd for evaluation and forwarded to the quality engineer for investigation.The dhr for the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.A visual check of the blister and foam insert confirmed that there is a hair present in the packaging.An issue evaluation has been raised on the manufacturing site to investigate further.

Event Description

Packaging: hair found in inner sterile packaging.

• Brand Name: OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6829884
• MDR Text Key: 83985754
• Report Number: 3002806535-2017-00861
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 154722
• Device Lot Number: 3964298
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 03/27/2018; 03/27/2018
• Supplement Dates FDA Received: 03/28/2018; 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1