MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PRODIGY SM STAT LNG LT 15.0MM; PRODIGY HIP STEM : HIP FEMORAL STEM

Catalog Number 152024050

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Synovitis (2094); Tissue Damage (2104); Burning Sensation (2146); Test Result (2695); No Code Available (3191)

Event Date 06/30/2016

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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional: "attorney".(b)(4).

Event Description

Litigation papers allege the patient was revised due to implant failure.Update: in addition to what was previously reported, litigation alleges the patient suffers from damage to her hip joints and body.Update: litigation papers allege the patient had pain and a lump and that "the top of implant needs replaced".Update: patient was revised due to pain.Removed head and liner.Update: in addition to what were previously alleged, ppf alleges metal wear, metallosis and elevated metal ions.Doi: (b)(6) 2004; dor: (b)(6) 2016; (left hip).

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.Per (b)(4) a medical record review is not required for this complaint record investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.Udi: (b)(4).Patient code: no code available used for surgical intervention and blood heavy metal increased.

Event Description

Pfs and medical records received.In addition to what previously alleged, pfs alleged burning.After review of medical records patient was revised to address failed left hip replacement, metal on metal reaction.Patient alleges pain and elevated metal ions.Exam showed weakness sentinel lymph.Operative notes indicated synovitis with clear fluid.There was an abundance of gray caseous tissue.The hip was then dislocated atraumatically.Head was removed.There was no trunnionosis.Findings show well fixed and in appropriate position.The acetabulum was well fixed.A metal-on-metal liner was removed.The pelvis was leveled using fluoroscopy and the inserter was placed goniometer showed the anteversion to be 21 degrees.Given the amount of osteolysis we felt it was more prudent to proceed with liner exchange rather than a cup removal to correct just a degree of anteversion.

• Brand Name: PRODIGY SM STAT LNG LT 15.0MM
• Type of Device: PRODIGY HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 8570426
• MDR Text Key: 143738270
• Report Number: 1818910-2019-92184
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 152024050
• Device Lot Number: W77GH1007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 58