MAUDE Adverse Event Report: DEPUY INTL., LTD. 8010379 UNKNOWN DEPUY METAL FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-HIP

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 03/19/2015

Event Type  Injury  

Manufacturer Narrative

Additional 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 the subject of litigation or a legal claim and complete product detail is not available at this time.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

Litigation papers allege the patient experienced debilitating pain, discomfort, and soreness, in the area of her hip implant, thereby, negatively affecting her ability to perform activities of daily living.Additionally alleged friction and wear between the cobalt-chromium metal head and cobalt-chromium metal liner caused toxic cobalt-chromium metal ions and particles to be released into the patient's blood, tissue and bone surrounding the implant.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.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.

• Brand Name: UNKNOWN DEPUY METAL FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5312725
• MDR Text Key: 33933733
• Report Number: 1818910-2015-37908
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: UNK-HIP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2016
• 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: 64 YR