MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. - 8010379 UNKNOWN DEPUY ASR FEMORAL HEAD; HIP FEMORAL HEAD

Catalog Number UNK-ASR

Device Problem Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 05/19/2014

Event Type  Injury  

Event Description

Asr revision reported via sales rep, left, reason(s) for revision : none provided.Der advises a 54 asr, size 6 sum poro and a +2 47 head where originally implanted and that only the cup was revised however no product /lot number provided.Update rec'd (b)(6) 2015 - medical records received.Name corrected.Patient was revised to address metallosis, pain, and increasing metal ion levels.Upon revision, brown necrotic tissue, reactive tissue, and osteolysis were noted.Records indicate that the femoral head was revised.The stem remained in situ.The femoral head, sleeve and stem are being added to the complaint.This complaint was updated on (b)(6) 2015.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 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.Wwcapa (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.Udi: unavailable.For any product information received.  depuy synthes has been informed that the catalog number and lot number is not available.

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. - 8010379; st. anthony's rd; leeds LS11 8 D; UK LS11 8 DT
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4860989
• MDR Text Key: 21473501
• Report Number: 1818910-2015-24087
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/15/2015

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?: No
• Device Operator: Physician
• Device Catalogue Number: UNK-ASR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 06/22/2015
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 74