MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011090

Device Problems Material Disintegration (1177); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

(b)(4).Reason for original complaint ¿ litigation papers allege the following: after the surgery, friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused large amounts of toxic cobalt-chromium metal ions and particles to be released into patient's blood and tissue and bone surrounding the implant.As a result, patient has been experiencing severe pain and discomfort and inflammation in his left thigh and groin.He also experiences a popping and snapping sensation in his hip-joint when walking or moving to and from a sitting position.Due to patient's chronic pain and discomfort and other symptoms, patient will likely need to undergo revision surgery to replace the implant.Update (b)(4) 2015 - pfs received.After review of the pfs for mdr reportability, the depuy unknown hip is being change to an unknown liner and an unknown stem and femoral head are being added to the complaint for the alleged high metal ions.

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 code(s) was 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

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

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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.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.

Event Description

Ppf has no new allegation.Added date of revision, event date, lawyer, surgeon, facility name and revision hospital.Updated unknown head, liner and stem.Doi: (b)(6) 2009 - dor: (b)(6) 2014 (left side).

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.  udi: (b)(4).

• Brand Name: SUMMIT POR TAPER SZ3 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4785721
• MDR Text Key: 5852517
• Report Number: 1818910-2015-21195
• 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: Other,consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2015

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: 08/31/2019
• Device Catalogue Number: 157011090
• Device Lot Number: D28GL1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided; 10/16/2018; 01/01/2019
• Supplement Dates FDA Received: 06/10/2015; 10/17/2018; 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 103