MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN COPELAND SHOULDER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problem Damage to Ligament(s) (1952)

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.Current information is insufficient to permit conclusions as to the cause of the events.Event details and product identification was not provided for the patient mentioned in the journal article.Initial reporter - the article was written by s.Ajami, g.W.Blunn, s.Lambert, s.Alexander, m.Foxall smith, m.J.Coathup.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "histological evaluation of two designs of shoulder surface replacement implants" which aimed to examine the outcomes of the extent of osseointegration in two designs of shoulder resurfacing implants.A patient was identified in the article that was revised fourteen months post-implantation due to glenoid wear and rotator cuff tear.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN COPELAND SHOULDER
• Type of Device: PROSTHESIS, SHOULDER
• 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: daniel tilbury ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 5685106
• MDR Text Key: 46093266
• Report Number: 3002806535-2016-00294
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR