MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. GLOBAL SHD HUM HEAD 48MM LG; SHOULDER HEAD/GLENOSPHERE

Catalog Number 113450000

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  No Answer Provided  

Event Description

New etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint ¿ patient contact complaining about pain and lack of range of motion.Update rec'd 07/22/2014 - (b)(4) of depuy's legal department spoke with the patient, who was calling to request compensation because he had his shoulder revised on (b)(6) 2014 because it "quit working." he further stated that he always had problems with it, that it wouldn't go all the way up, or behind his back.He also stated that he had to quit his job as a certified technician and truck driver.He said that he has the explant and agreed to return it to depuy for examination.(b)(4) told patient we wound return the explants to him at the conclusion of our investigation.She is following up with the patient for authorizations for medical records and xrays.

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

The device associated with this report was not returned.Review of the device history records did not reveal any manufacturing deviations or anomalies.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 additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: GLOBAL SHD HUM HEAD 48MM LG
• Type of Device: SHOULDER HEAD/GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3999461
• MDR Text Key: 4688197
• Report Number: 1818910-2014-25348
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK914695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113450000
• Device Lot Number: SX1GC1008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/1998
• 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