MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157001090

Device Problems Corroded (1131); Degraded (1153); Metal Shedding Debris (1804)

Patient Problems Nausea (1970); Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Litigation papers allege corrosion and friction wear is believed to have caused amounts of toxic cobalt-chromium metal debris to be released into the patient's tissue surrounding the implant.The patient began experiencing pain and difficulty with the implant.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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

(b)(4).

Event Description

Pfs and medical records received.Pfs alleges physical injuries, pain in hip and low back area, difficulty in standing or walking, difficulty sleeping, numbing legs, clicking sound in hips and nausea.After review of medical records for mdr reportability, there is no new alleged information reported.

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: SUMMIT POR TAPER SZ3 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5366350
• MDR Text Key: 35964054
• Report Number: 1818910-2016-10759
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/04/2016

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: 11/06/2016
• Device Catalogue Number: 157001090
• Device Lot Number: A5WBS1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided; 02/05/2018; 01/31/2018; 11/22/2019
• Supplement Dates FDA Received: 03/03/2016; 02/14/2018; 02/15/2018; 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 147