MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SUMMIT POR TAPER SZ8 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011150

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

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 05/04/2017

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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

The patient was revised to address pain and elevated ion levels.It was also indicated that patient had corrosion at the head and neck taper.

Manufacturer Narrative

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

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.

Event Description

After review of medical records patient was revised to addressed failed right hip arthroplasty.The acetabulum was exposed circumferentially.There was some evidence of ongrowth medially but there was no loss of cortical bone.It was noted that there were osteophytes noted anteriorly and also noted a calcification in the anterior capsule which was excised.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: b5, d11, e1, e2 and h6 (patient and device codes).H6 patient code: no code available (3191) used to capture the limb asymmetry and surgical intervention.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

The surgeon commented that it appeared the patient had been eccentrically reamed and did not have bone cup contact on the front of the shell.

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.

• Brand Name: SUMMIT POR TAPER SZ8 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6607532
• MDR Text Key: 76505932
• Report Number: 1818910-2017-18929
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P040023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 157011150
• Device Lot Number: C4VBY1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +8.; ASR ACETABULAR CUPS 60.; ASR UNI FEMORAL IMPL SIZE 53.
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 102