MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ADAPTER SLEEVES 12/14 +2; HIP FEMORAL SLEEVE

Catalog Number 999800312

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

New unity record created in order to update legacy complaint (b)(4).Litigation alleges that patient suffers from constant hip pain, back pain and discomfort.It is sometimes not possible for patient to perform her routine daily activities due to the pain.The incision site around the hip implant sometimes still opens up and bleeds years after her original implant surgery.Additionally, it is alleged that patient has elevated metal ion levels.Patient's preliminary disclosure form was received on 6/29/2012, which provided part/lot information.Doi: (b)(6) 2008 - dor: none reported (left hip) **patient is a resident of (b)(6).Update nov 15 and 28, 2017: medical records received.After review of medical records for the mdr reportability, in addition to what was previously reported, the patient was revised to address metallosis and trunnionosis.Revision notes reported a metallosis-type fluid, significant trunnionosis with grey metal black particles in the femoral head, and no real incorporation of bone into the acetabular shell.Laboratory result for cobalt is above 7 ppb.Clinical notes reported inability to bear weight, history of wound dehiscence, soft tissue atrophy, limited rom, decreased motor strength, flexed forward ambulation with cane and significant limp.X-ray shows the femoral stem is somewhat proud and slightly varus.Added asr taper sleeve and tri-lock stem.Doi: (b)(6) 2008 dor: (b)(6) 2017 (left hip).

Manufacturer Narrative

Product complaint # :(b)(4).Investigation summary : this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.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 +2
• Type of Device: HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7114336
• MDR Text Key: 94752209
• Report Number: 1818910-2017-51523
• Device Sequence Number: 1
• Product Code: KWA
• 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,other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2013
• Device Catalogue Number: 999800312
• Device Lot Number: 2631025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• Date Device Manufactured: 05/13/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR