MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ2 HI OFF; HIP FEMORAL STEM

Catalog Number 157011080

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); Foreign Body Reaction (1868); Myocardial Infarction (1969); Pain (1994); Discomfort (2330); No Information (3190); No Code Available (3191)

Event Date 04/30/2012

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - a clinical patient was revised to address high metal ion levels, discomfort, and slight metallosis.Update rec'd 10/28/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from pain, elevated metal ion levels, and synovium that was stained with metallic tissue.A doi was identified.A stem is being added to address the elevated metal ion levels.

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.Udi: unavailable.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.

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 still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Event Description

Update 12/22/2014- pfs and medical records received.After review of the medical records for mdr reportability, the stem is being added for the alleged high metal ions (no lab results provided).There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

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.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 caused or contributed to the potential event described in this report.Udi: (b)(4).

Event Description

Ppf alleges dislocation, stroke, heart attack, and metal wear.

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.H10 additional narrative: added: h6 (device codes).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 SZ2 HI OFF
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4274143
• MDR Text Key: 16853691
• Report Number: 1818910-2014-32416
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/22/2014

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: 09/12/2008
• Device Catalogue Number: 157011080
• Device Lot Number: X3WC61
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/18/2019; 12/19/2019
• Supplement Dates FDA Received: 01/21/2015; 02/26/2015; 10/08/2019; 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 71