MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 ASR UNI FEMORAL IMPL SIZE 47; HIP FEMORAL HEAD

Catalog Number 999890247

Device Problems Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Tissue Damage (2104); Weakness (2145); Discomfort (2330)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Litigation received; patient alleges tissue damage, shedding of metal debris into the bloodstream, decreased mobility, elevated metal ions, pain and discomfort.

• Brand Name: ASR UNI FEMORAL IMPL SIZE 47
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5650630
• MDR Text Key: 45041687
• Report Number: 1818910-2016-19199
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/26/2016

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: Health Professional
• Device Expiration Date: 08/04/2019
• Device Catalogue Number: 999890247
• Device Lot Number: 2979442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2009
• 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: 64 YR