MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT PS ANAT FM R 60MM; COOPER VISION LTD, UNITS 3-11 MACE INDUSTRIAL ESTATE, MACE LANE, ASHFORD TN24 8E

Catalog Number 183104TNBN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Local Reaction (2035)

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

Patient is suspected allergic reaction to the material in the implant.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the 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.The surgeon has been provided with the chemical composition of the products.No revision surgery reported to date.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

Suspected allergic reaction to the material in the implant.The surgeon requested chemical composition of the products.

• Brand Name: TINBN VG INT PS ANAT FM R 60MM
• Type of Device: COOPER VISION LTD, UNITS 3-11 MACE INDUSTRIAL ESTATE, MACE LANE, ASHFORD TN24 8E
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8098910
• MDR Text Key: 128184661
• Report Number: 3002806535-2018-01206
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 183104TNBN
• Device Lot Number: 6189953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR