MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVES 12/14 +5; HIP FEMORAL STEM/SLEEVE

Catalog Number 999800315

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 04/14/2010

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.For any product information received.Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.

Event Description

Litigation received alleging that the patient suffers pain, disability, and excessive levels of chromium cobalt.Update (b)(6) 2013 - plaintiff¿s preliminary disclosure form was received, which identified dob, doi, and part/lot information.The complaint and associated mdrs were updated.There was no new information that would change the outcome of the investigation.Update rec'd (b)(6) 2013 - ppd and medical records received.Dor is (b)(6) 2010.During the (b)(6) 2010 operation the femoral head and cup were revised for a pseudotumor.A competitor cup and poly liner were implanted and new depuy head was placed.There is no new additional information that would affect the existing mdr decision.The complaint was updated on: (b)(6) 2014.Update (b)(6) 2017.Pfs and medical records received.After the review of medical records for mdr reportability, it was stated that the patient was revised to address pain and pseudotumor growth from metal on metal articulation.Revision notes reported severe damage to all soft tissues and 50 cc of cloudy fluid with only 80 white cell count thought to be due to mom pseudotumor.There is no metal ion level information provided within the medical records.This complaint was updated on: (b)(6) 2017.

Manufacturer Narrative

No device associated with this report was received for examination.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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 7176268
• MDR Text Key: 96807933
• Report Number: 1818910-2018-10031
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2012
• Device Catalogue Number: 999800315
• Device Lot Number: 2469925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2007
• 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 Sex: Male