MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR UNI FEMORAL IMPL SIZE 45; HIP FEMORAL HEAD

Catalog Number 999890245

Device Problems Corroded (1131); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Ossification (1428); Itching Sensation (1943); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Cramp(s) (2193); Discomfort (2330); Not Applicable (3189)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy synthes has been informed that the catalog number and lot number is not available.

Event Description

Patient was revised due to fluid and pain.

Manufacturer Narrative

The asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.(b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Medical records received.After review of medical records for the mdr reportability, patient was revised to address pain.Revision notes reported of fluid collection approximately the volume of a couple of golf balls, slight corrosion at the trunnion, the acetabular capsule appeared to be reasonably well positioned, however, it was then eventually removed.Clinic visits reported of swollen hip, sting, itchiness, muscle cramps, weakness, increased squeaking and increased metal ions.X-ray reported of some minor lucency at the acetabular dome, minor heterotopic ossification at the tip of the trochanter and periprosthetic fluid collection.Laboratory result for cobalt ions was above 7ppb.

Manufacturer Narrative

(b)(4).

Event Description

Claim letter and implant sticker sheets received.Claim letter alleges defective implants, elevated cobalt and chromium ion levels, a squeaking sensation felt throughout plaintiff's body, extreme pain when walking, discomfort, difficulty to step up and over any objects, altered gait and low back pain.It was also indicated that the patient began losing her balance and would fall down approximately once a week due to the increased chromium and cobalt levels in her blood and that this caused her to use a cane starting in 2014 for fear of falling as well as the development of myopathy in 2015.

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

Asr medical records and implant sticker sheet received.After review of medical records, the patient was revised due to pain and elevated metal ions.Operative notes reported that patient was debrided of some necrotic tissue and our stem appeared to be appropriately anteverted.It appeared to be well fixed to the bone.There were some slight corrosion at the trunnion.

Manufacturer Narrative

(b)(4).This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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.

Manufacturer Narrative

Product complaint # (b)(4).This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: ASR UNI FEMORAL IMPL SIZE 45
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 5724349
• MDR Text Key: 47391430
• Report Number: 1818910-2016-21334
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: PK032659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Catalogue Number: 999890245
• Device Lot Number: 2491604
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR