MAUDE Adverse Event Report: DEPUY (IRELAND) 9616671 UNKNOWN DEPUY SROM SLEEVE; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 11/30/2016

Event Type  Injury  

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

The patient was revised to address metallosis.Update rec'd 12/09/2016 - clinical der rec'd indicating revision for adverse tissue reaction.No new information to change mdr decision.*complaint was updated on 12/27/2016.Update rec'd 1/11/2017: medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain , metallosis, stem in varus position (distal stem protrusion into the cortex) with migration.It also mentioned a pending femoral fracture distally to the isthmus and lateral cortex.Several office notes indicate a vertical cup (no measurements provided), but the cup wasn't revised during the revision.Lab levels provided indicate normal cobalt and chromium levels.The srom stem and sleeve are being added to the complaint.This complaint was updated on: 1/27/2017.

Manufacturer Narrative

No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination(s).A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible for the unknown lot code(s).Medical records were reviewed.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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.

• Brand Name: UNKNOWN DEPUY SROM SLEEVE
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6282577
• MDR Text Key: 65941031
• Report Number: 1818910-2017-11557
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 79