MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 C-STEM SZ2; HIP FEMORAL STEM/SLEEVE

Catalog Number 961162000

Device Problems Fracture (1260); Loss of Osseointegration (2408); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/25/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(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

Patient underwent a revision to address alval/soft tissue reaction, metallosis, stem loosening and fracture and pain.

Manufacturer Narrative

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

Event Description

Patient underwent a revision to address alval/soft tissue reaction, metallosis, elevated metal ions, stem loosening and fracture and pain.

• Brand Name: C-STEM SZ2
• Type of Device: HIP FEMORAL STEM/SLEEVE
• 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: 6145598
• MDR Text Key: 61451852
• Report Number: 1818910-2016-32801
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2011
• Device Catalogue Number: 961162000
• Device Lot Number: 2127544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention