MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN DEPUY FEMORAL STEM; HIP FEMORAL STEM

Catalog Number UNK-HIP

Device Problems Corroded (1131); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 12/14/2009

Event Type  Injury  

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - patient revised for pain, found loose cup and metallosis.Update 3/29/2013- ppd and medical records received.This complaint is now legal.This complaint is for the right hip.After review of the medical records for mdr reportability, the revision operative note indicated pain, metal debris/stained tissues, stem was sitting proud and caused leg length discrepancy, and the cup was not noted to be loose.The patient was revised again on 1/17/2011 for a loose stem and residual metallosis from the previous revision.The was revised and the femoral head that was removed was replaced.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: 2/23/2015.

Manufacturer Narrative

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.Udi: unavailable.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

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Examination of the reported devices was not possible as they were not returned.The asr devices have been discontinued/obsolete/recalled from the market and will not be investigated further.A search of the complaints databases and/or review of device history records was not possible as the necessary femoral stem product/lot code combination was not provided.The investigation can draw no conclusions with the information provided.Based on the inability to determine a root cause, the need for corrective action has not been identified.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 FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4542256
• MDR Text Key: 5359289
• Report Number: 1818910-2015-14340
• 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,Distributor
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2015

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: Physician
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2015
• 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: 69 YR
• Patient Weight: 91