MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN SHOULDER GLENOSPHERE; SHOULDER HUMERAL HEADS

Catalog Number UNK SHOULDER GLENOSPHERE

Device Problem Fracture (1260)

Patient Problems Pain (1994); Tissue Damage (2104); Not Applicable (3189)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address pain and loosening of the glenosphere to metaglene at the bone to implant interface due to fall.Surgeon opened the shoulder and saw metallosis explanted the +9mm spacer/38 +3 poly, 38 ecc head and discovered the central screw was broken and the metaglene was loose.Explanted 4 screws, all parts/broken parts retrieved and converted to a delta cta head.Doi: unknown.Dor: (b)(6) 2018.Right shoulder.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN SHOULDER GLENOSPHERE
• Type of Device: SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7897509
• MDR Text Key: 120984562
• Report Number: 1818910-2018-70025
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER GLENOSPHERE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 91