MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STMLG36+21CR8L 20X15X225N; JRN : HIP FEMORAL STEM

Catalog Number 563020N

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Fall (1848); Inflammation (1932); Scarring (2061); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Litigation alleges the patient suffers from pain, discomfort, and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.Update rec'd 12/8/2014 - sales rep reported revision surgery.Patient was revised to address instability.The stem is being added to the complaint for elevated metal ion levels.The complaint was updated on: 1/2/2014.

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.

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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).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.Depuy synthes has been informed that the catalog number and lot number is not available.

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Ppf, pfs and medical records received.In addition to what were previously alleged, ppf alleges loosening of cup, metal wear, metallosis and elevated metal ions.Pfs alleges that the patient felt like there was scraping sensation in his hip, walking difficulty and fell down every once and a while.Surgeon recommended revision surgery due to loose component and metallosis.After review of medical records, the patient was revised to address cup loosening, metallosis and instability.Revision notes reported that hip was found to be dislocated, synovial scarring, and grossly loose cup.It was also found that the stem is 20 degrees retroverted.The sleeve was left in place and stem was rotated over 40 degrees to provide appropriate anteversion then was reinserted.Pathology report is positive for acute inflammation.Lab data shows metal ion levels were above 7 ppb.Doi: (b)(6) 2007 - dor: (b)(6) 2014 (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.Additional 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.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.

• Type of Device: JRN : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 4378969
• MDR Text Key: 5238018
• Report Number: 1818910-2015-10054
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Distributor,distributor,health p
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2010
• Device Catalogue Number: 563020N
• Device Lot Number: 1901796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 113