MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PRODIGY LG STAT LNG LT 18.0MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number 152062050

Device Problems Corroded (1131); Biocompatibility (2886)

Patient Problems Pain (1994); Osteolysis (2377); Test Result (2695)

Event Date 01/21/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 osteolysis and metal on metal reaction.Revision note reported of elevated chromium and cobalt ions levels, however, there was no laboratory result provided before the first revision.There was corrosion at the taper.Doi: (b)(6) 2007; dor: (b)(6) 2013, (left hip) first revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: investigative update: 20 / august / 2021 product and/or lot information has been provided.Patient x-ray images and a singular device photograph have also been provided for review.No device associated with this report was received for examination.Provided x-ray images are paper copies that are unclear in nature.That being noted nothing indicative of a product problem is identified.A photograph of the explanted femoral head only has also been provided.The device is within a tinted blue plastic package.It does not aid in this investigation.No conclusions can be drawn or root cause for the problems reported identified using the provided images.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: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: PRODIGY LG STAT LNG LT 18.0MM
• Type of Device: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8607496
• MDR Text Key: 144955546
• Report Number: 1818910-2019-93367
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K000207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/21/2013

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 Catalogue Number: 152062050
• Device Lot Number: X5FDK1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 09/03/2021
• Supplement Dates FDA Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 87