MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PRODIGY SM STAT SHT LT 12.0MM; HIP FEMORAL STEM/SLEEVE

Catalog Number 152016050

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Inflammation (1932); Pain (1994); Skin Irritation (2076); Discomfort (2330); Test Result (2695); Not Applicable (3189); No Information (3190)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was revised to address high level metal ions.It was also reported that the surgeon decided to remove the ultamet liner and replace with altrex liner, while he was doing a revision, he changed the metal head to ts ceramic.

Event Description

Litigation alleges friction and wear causing toxic metal ions, severe pain, discomfort and inflammation.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.

Event Description

Complaint description: patient was revised to address high level metal ions.It was also reported that the surgeon decided to remove the ultamet liner and replace with altrex liner, while he was doing a revision, he changed the metal head to ts ceramic.Update nov 15, 2017: litigation received.Litigation alleges friction and wear causing toxic metal ions, severe pain, discomfort and inflammation.Added complainant information.This complaint was updated on nov 20, 2017.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PRODIGY SM STAT SHT LT 12.0MM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6917982
• MDR Text Key: 88374129
• Report Number: 1818910-2017-25965
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 152016050
• Device Lot Number: W2CEN1001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR