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

Catalog Number UNK-ASR

Device Problems Metal Shedding Debris (1804); Loss of Osseointegration (2408)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Pain (1994); Synovitis (2094); No Code Available (3191)

Event Date 05/16/2014

Event Type  Injury  

Event Description

Litigation papers allege patient has suffered or is at risk to suffer: synovitis, mechanical complications, tissue necrosis and inflammation, metallosis, loosening, chromium and cobalt toxicity and pain.Comment: it should be noted that the law firm uses the same (or similar) complaint for all patients, so it is possible these symptoms are not specific to this patient.

Manufacturer Narrative

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 this investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

Event Description

Update rec¿d (b)(6) 2014 - sales rep reported revision surgery.Patient was revised to address pain.There is no new additional information that would affect the investigation.This complaint was updated on: (b)(6) 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.

• Brand Name: UNKNOWN DEPUY ASR FEMORAL HEAD
• Type of Device: FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL., LTD - 8010379; st. anthony's rd.; leeds, leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTL., LTD - 8010379; st. anthony's rd.; leeds, leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3552145
• MDR Text Key: 4102920
• Report Number: 1818910-2014-10179
• Device Sequence Number: 1
• Product Code: KXA
• 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,Company Representative
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• 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): Other
• Patient Age: 60 YR