MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN PINNACLE ACETABULAR CUP; HIP ACETABULAR CUP

Catalog Number UNK-HIP

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Powerpoint presentation received from dr.(b)(6) states that multiple patients were revised to address dissociation.

Manufacturer Narrative

Follow-up with the complainant has been conducted for the catalog and lot number and this information is not available.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 investigation is unable to draw any conclusions from the provided information.It is possible that these patients and events have been previously reported to depuy.No device, product/lot combinations or any specific patient information has been provided.Follow up for additional information was not successful.Cases of pinnacle disassociation events are trended via (b)(4) post market survelliance procedure.A need for corrective action has not been identified.Continue to monitor.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: UNKNOWN PINNACLE ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• 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: 4230859
• MDR Text Key: 5065824
• Report Number: 1818910-2014-31282
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2015
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention