MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY METAGLENE SCREWS; MISC EXTREMITY IMPLANT

Catalog Number UNK-EXTREM

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 04/27/2015

Event Type  Injury  

Event Description

Patient was revised to address pain,glenosphere and metaglene loosening.It was reported that there was metalosis present due to the glenosphere spinning on the metaglene.Metaglene screws quantity of 4 were removed.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Update 8/24/15.Medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain, glenosphere was loose on top of the glenoid.It appeared to be spinning causing the metallosis.Osteolysis was also mentioned.The humeral stem was noted to be well fixed.The primary operative note still hasn't been provided.There is no new additional information that would affect the existing mdr decision.The complaint was updated on:9/18/2015.

Manufacturer Narrative

The device associated with this report were not returned.Review of the device history records and/or a lot specific complaint database search was not possible as the product and lot codes required were not provided.The initial reporting stated no additional investigational inputs were available.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN DEPUY METAGLENE SCREWS
• Type of Device: MISC EXTREMITY IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 4773757
• MDR Text Key: 20449602
• Report Number: 1818910-2015-20781
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNK-EXTREM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85