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

Catalog Number UNK-ASR

Device Problems Metal Shedding Debris (1804); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Osteolysis (2377); Not Applicable (3189)

Event Date 10/23/2013

Event Type  Injury  

Event Description

Litigation alleges extraordinary injuries, pain, suffering, stress and anxiety.

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.(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.

Manufacturer Narrative

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

Event Description

Update rec'd 10/7/2014 - medical records received.Patient revised to address metallosis.Upon revision, tissue necrosis, bone loss, and scarring were noted.The information received does not change the mdr decision.This complaint was updated on: 11/04/2014.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Depuy still considers this investigation closed.

Event Description

Update rec'd 08/15/2014- litigation papers received.Litigation alleges discomfort and clunking.There is no new additional information that would affect the investigation.The complaint was updated on: 09/04/2014.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD. - 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 4052865
• MDR Text Key: 4902399
• Report Number: 1818910-2014-27106
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,consumer,health profess
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• 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
• Date Manufacturer Received: 12/23/2020
• 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