MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-120

Device Problems Corroded (1131); Degraded (1153); Material Discolored (1170); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Complaint description: new etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation papers allege the patient suffers from pain, mental anguish and elevated metal ion levels.Update rec¿d 5/1/2015 - plaintiff¿s preliminary disclosure form was received, which identified part/lot information from patient sticker sheet the complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.The complaint was updated on: 05/19/2015.Update mar 2, 2018: medical records received.After review of medical records for mdr reportability it was reported that the patient was revised to address wear, persistent pain and increasing heavy metal levels.Revision note stated, there was noted to be some corrosion at the trunnion.There were no laboratory values provided the blood metal levels.Added the stem and sleeve product.

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

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

Event Description

After review of medical records the patient was revised to address pain, heavy metal levels and has previous heart disease.A prosthetic wear in the right hip.Operative notes reported brownish fluid taken and was cultured.There was a corrosion at the trunnion and was removed.Doi: (b)(6) 2006; dor: (b)(6) 2017; right hip.

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.

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).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

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.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.

• Brand Name: SUMMIT POR TAPER SZ6 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7380831
• MDR Text Key: 103784268
• Report Number: 1818910-2018-56334
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059370
• UDI-Public: 10603295059370
• 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: 03/02/2018

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 Model Number: 1570-01-120
• Device Catalogue Number: 157001120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 10/02/2018; 03/26/2019; 04/29/2020; 04/29/2020
• Supplement Dates FDA Received: 09/17/2018; 10/23/2018; 04/05/2019; 05/06/2020; 05/20/2020
• 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: 123