MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX8MM; HIP OTHER IMPLANT

Catalog Number 121708500

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Sepsis (2067); Toxicity (2333); Impaired Healing (2378); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 06/10/2015

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.(b)(4).

Event Description

Patient was revised to address wound healing issues, infection and femoral stem loosening.Update rec'd 8/31/2015: litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from toxic cobalt chromium metal debris, pain, and limited mobility.A doi has been added.The head and liner are now being reported to address general allegations of metal on metal.Update :12/21/2015- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported doi of (b)(6) 2010 and medical records confirmed same, doi will be updated.Pfs reported difficulty walking, pain, red lump at incision line, drainage on scar lump (b)(6) 2015, infection discovered (b)(6) 2015 during implant removal, left hip issues causing right leg to deteriorate and the patient has no left hip joint and hip damage related to removal process.Medical records reported a pseudotumor, draining sinus at mid-portion of lateral hip incision, septic granulation tissue, minimal staining of tissues related to metal, nonunion of the greater trochanter and abductor muscle deficiency related to prior injury, surgery, and infection.Pathology reports metallosis, necrosis, inflammation in tissues.The components were removed and antibiotic cement spacers placed.The labs results for metal ions were less than 7 parts per billion and not reportable.Medical records reported femoral stem was removed easily without bone loss but did not state it was loose.The screws will be added to the complaint for infection and will be reported since infection was now confirmed.The cup will also be reported.The complaint was updated on: jan 12, 2016.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head, liner, and the 413431 bone screw.Per procedure, the femoral head and liner are exempt from device history record review.Device history records were reviewed for the bone screw and no related manufacturing deviations or anomalies that would have contributed to the reported event were identified.No other reports were found against the remaining product/lot code combinations.The patient was implanted with depuy devices in (b)(6) 2010 and revised for infection in (b)(6) 2015.It is not reasonable to conclude the devices contributed to the patients reported infection 5 years after implantation.Based on the inability to determine root cause, the need for corrective action has not been indicated.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.

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 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.H10 additional 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.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, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX8MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 5366246
• MDR Text Key: 35966622
• Report Number: 1818910-2016-10738
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2015

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: 05/19/2018
• Device Catalogue Number: 121708500
• Device Lot Number: CT7BR4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided; 12/10/2019
• Supplement Dates FDA Received: 03/15/2016; 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 117