MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SOL SYS 10/15.0 L LRG STAT; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number 157210150

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Unspecified Infection (1930); Tissue Damage (2104); Joint Dislocation (2374)

Event Date 03/26/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint #
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> (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received.Pfs and medical records received.Pfs alleges dislocation, infection, muscle damage, fracture of the trochanter and anemia.After review of medical records for the mdr reportability, patient was revised to address peri-implant infection.Operative findings reported of copious purulent materials, infected nonunion of the greater trochanteric area, cable wire was noted loose also with the femoral component.Radiographic evaluation showed a posterior hip dislocation.Clinical notes reported of instability of left hip due to dislocation.Doi: (b)(6) 2011- dor: (b)(6) 2012; (left hip).

Manufacturer Narrative

Product complaint #
=
> pc-(b)(6).Investigation summary
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> no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Udi:(b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SOL SYS 10/15.0 L LRG STAT
• Type of Device: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7164295
• MDR Text Key: 96370135
• Report Number: 1818910-2018-50216
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K030979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

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 Catalogue Number: 157210150
• Device Lot Number: C3JBX1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/30/2018; 02/26/2019; 08/06/2019
• Supplement Dates FDA Received: 01/31/2018; 03/07/2019; 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 52