MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR 300 SPIKED CUP SIZE 56; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999830756

Device Problem Noise, Audible (3273)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Distress (2329); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.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.Addendum added (b)(6) 2020.Following further review, it was identified that this was an asr product.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be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.(b)(4) superseded by (b)(4).

Event Description

 patient had s depuy asr total acetabular implant.The letter alleges pain, functional limitations, rise in chromium and cobalt ions in blood and urine, articular crepitation and distress.The patient then underwent right hip revision surgery and it was observed that there was rough ossification departing from the femoral neck up to the acetabulum, brownish fluid and metallosis.Histological examination indicates chronic non-specific synovitis with an area of sclerosis and meta-hemorrhage foci.Added lawyer, patient date of birth, patient sex, date of implant, operative hip, patient harms, date of explant/event date, implant duration, patient and pe codes, revising surgeon and surgeon.Doi: (b)(6) 2007 - dor: (b)(6) 2015 (right hip).

• Brand Name: ASR 300 SPIKED CUP SIZE 56
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9935550
• MDR Text Key: 189705367
• Report Number: 1818910-2020-10404
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 999830756
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 69 YR