MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Thrombosis (2100); No Code Available (3191)

Event Date 09/01/2005

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The literature article entitled, "modular cementless total hip arthroplasty for hip infection sequelae" by seung-jae lim, md and you-soo park, md published by orthopaedics on september 2005 was reviewed for mdr reportability.The article's purpose: "to present the results of primary cementless tha, comprising a modular stem and a press-fit metal-backed socket, which was implanted between 1994 and 2000 in patients whose history and clinical radiographi findings suggested late infection sequelae of the hip joint." the results came from 58 patients with 58 primary tha in which depuy porous-coated s-rom modular stems were utilized.Results of complications include seven patients with a fair or poor score: "four were explained by either socket loosening or infection recurrence, but the remaining three were not associated with hip arthroplasty." no indications are given if patients received revision or other interventions to address these adverse events.Complications: "two linear femoral fractures occurred during stem insertion, both of which were treated with cerclage wirings and healed uneventfully.One vancouver b1-type periprosthetic fracture occurred at the stem tip area 2 weeks after the index arthroplasty.The patient was successfully treated by open reduction and internal fixation, with retention of the stem.Other postoperative complications included transient sciatic nerve palsy in one hip and deep vein thrombosis in another.During follow-up, no hip dislocated." no further information is given in regards to generalized adverse events or complications with the exception of a case with patient identifiers which is captured in a linked complaint.

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).No device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9110790
• MDR Text Key: 164631068
• Report Number: 1818910-2019-105359
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

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: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention