MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PRODIGY SM STAT LNG RT 13.5MM; HIP FEMORAL STEM/SLEEVE

Catalog Number 152021050

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 07/21/2013

Event Type  Injury  

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.Udi: (b)(4).

Event Description

Litigation alleges pain, discomfort, elevated cobalt and chromium levels and limited mobility.Update 2/19/2016, 2/28/2016, 2/29/2016, 3/1/2016 & 3/2/2016 medical records received.Medical records were reviewed for mdr reportability.Stem is being added for allegation of elevated metal ions.

Manufacturer Narrative

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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

Depuy still considers this investigation closed at this time.

Event Description

Update 4/22/2016, 5/4/2016 medical records received.Medical records reviewed for mdr reportability.Medical records report patient with mild effusion, mild swelling, decreased mobility, limping, numbness, tingling and weakness.There is no new additional information that would affect the existing investigation.The complaint was updated on: may 6, 2016.

Manufacturer Narrative

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.

• Brand Name: PRODIGY SM STAT LNG RT 13.5MM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 5480306
• MDR Text Key: 39672777
• Report Number: 1818910-2016-14666
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK000207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2006
• Device Catalogue Number: 152021050
• Device Lot Number: VJ7GR1004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 10/17/2019
• Supplement Dates FDA Received: 04/19/2016; 05/06/2016; 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 52