MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 10.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number 155401105

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 09/23/2013

Event Type  Injury  

Manufacturer Narrative

The devices associated with this report were not returned.A previous review of the device history records for the 1889611 lot code did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other reported incidents against the remaining product and lot combination.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for 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.

Event Description

Litigation alleges pain, discomfort and difficulty ambulating.Update rec¿d 4/29/2014 - pfs was received from legal, primary and revision medical records were received from legal.Records indicate that the patient was revised because of pain and heterotopic bone at the proximal femur.Records are available for further review.The complaint was updated on:05/19/14.Update rec'd 12/8/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from toxic cobalt-chromium metal ions, and inflammation.An unknown stem is being added to address toxic cobalt-chromium metal ions.

Manufacturer Narrative

Additional 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.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

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

Manufacturer Narrative

Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.

Event Description

Update (b)(6) 2016: pfs and medical records received.After review of the medical records for mdr reportability, surgeon noted in revision op note that patient had extensive heterotopic ossification present surrounding femoral prosthesis, neck, and anterior femoral cortex, limiting flexion and extension, and "main culprit for his excessive pain".Went on to state that he "did not see any evidence of corrosion and foreign body reaction to metal on metal articulation".There is no new additional information that would affect the existing mdr decision.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Ppf alleges metal wear and metallosis.Updated doi.

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.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. .

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).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: AML SM STATURE 10.5MM
• Type of Device: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 4371138
• MDR Text Key: 13003442
• Report Number: 1818910-2014-35392
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K012364
• 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,Followup

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 Catalogue Number: 155401105
• Device Lot Number: YH5D91000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 10/23/2018; 01/01/2019; 09/20/2019; 11/26/2019
• Supplement Dates FDA Received: 01/26/2015; 03/16/2015; 12/08/2016; 10/23/2018; 01/02/2019; 10/18/2019; 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 109