MAUDE Adverse Event Report: 1818910 DEPUY ORTHOPAEDICS, INC. SOL SYS 8/12.0 LRG ST; HIP FEMORAL STEM/SLEEVE

Catalog Number 157202121

Device Problem Fracture (1260)

Patient Problems Pain (1994); Discomfort (2330); Disability (2371)

Event Date 07/06/2012

Event Type  Injury  

Event Description

Litigation alleges the patient suffers from pain, disability, discomfort and a fractured femoral stem.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Visual examination of the returned device confirms a material fracture as reported.The returned femoral stem, device history and patient records have been reviewed by a member of the depuy synthes materials research team.Error in material or manufacture was not identified.A review of the manufacturing records for the solution stem (p/n 1572-02-121, lot # d51as1) found no deviations or anomalies noted that could have contributed to the fracture of the femoral implant.A complaint database search finds no additional reports against the provided product and lot combination.Review of provided medical records and patient xrays could not provide further conclusions.Based on the investigation, the need for corrective action was not indicated.

Manufacturer Narrative

(b)(4).Visual examination of the returned device confirms a material fracture as reported.The returned femoral stem, device history and patient records have been reviewed by a member of the depuy synthes materials research team.Error in material or manufacture was not identified.A review of the manufacturing records for the solution stem (p/n 1572-02-121, lot # d51as1) found no deviations or anomalies noted that could have contributed to the fracture of the femoral implant.A complaint database search finds no additional reports against the provided product and lot combination.Based on the investigation, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

• Brand Name: SOL SYS 8/12.0 LRG ST
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): 1818910 DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 3689994
• MDR Text Key: 20291748
• Report Number: 1818910-2014-14801
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/19/2014

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: 157202121
• Device Lot Number: D51AS1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/29/2014; 12/03/2014; 12/17/2014; 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2009
• 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