MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 GLOBAL AP PC STEM 8 MM; SHOULDER HUMERAL STEM/EPIPHYSIS

Catalog Number 113008200

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 11/11/2014

Event Type  Injury  

Event Description

Patient was revised to address glenoid loosening at the cement/implant interface.The cement manufacturer is unknown.It was reported that the loosening may have been due to the malpositioning of the stem, but is not confirmed at this time.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.

Event Description

Update rec'd 12/12/2014 - patient's medical records were received.Medical records were reviewed for mdr reportability.According to the records the patient had experienced a dislocation as well.The humeral head is being added to the complaint at this time.The complaint was updated on: 01/07/2015.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.X-rays and medical records were received and reviewed.X-rays found no evidence of anything indicative of a device nonconformance was found.From a medical perspective, based on the information available to be reviewed in the medical records, the complaint is not product related.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: GLOBAL AP PC STEM 8 MM
• Type of Device: SHOULDER HUMERAL STEM/EPIPHYSIS
• 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: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4298020
• MDR Text Key: 5191936
• Report Number: 1818910-2014-33461
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063652
• 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: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2015
• Device Catalogue Number: 113008200
• Device Lot Number: EY4GR1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2010
• 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: 61 YR
• Patient Weight: 83