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 Pain (1994); Pneumonia (2011); Heart Failure (2206); Joint Dislocation (2374); No Code Available (3191)

Event Date 05/21/2015

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, "total hip arthroplasty using non-modular cementless long-stem distal fixation for salvage of failed internal fixation of intertrochanteric fracture" written by xiaojun shi, md, zongke zhou, md, phd, jing yang, md, bin shen, md, pengde kang, md, phd, and fuxing pei, md on 21 may 2015 was reviewed for mdr reportability.The article reports on "all the patients had femoral reconstruction using a non-modular solution stem" (depuy).The mean follow up after salvage tha was 47.5 months and 3 of 31 patients died of unrelated diseases with the implant intact.Functional outcomes include: residual trochanteric low grade pain with no compromise of activities (6); limb-length discrepancy with a mean value of 7 mm - range of 5-15 mm (12); positive trendelenburg (denoting hip abductor weakness) in all patients but progressively diminished until all became negative.Complications: intraoperative nondisplaced femoral fracture treated with cerclage wire (2); dislocations within 2 weeks of initial implant successfully treated with closed reduction and bracing (2); delirium (1); pneumonia (1); and congestive heart failure (1).The article states, "there were no cases of nerve palsy or perioperative deaths." no further information provided on identity of other components besides the stem.No further information provided of further interventions for the complications.Impacted product: depuy solution stem.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> 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 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6107428552
• MDR Report Key: 9154300
• MDR Text Key: 167779755
• Report Number: 1818910-2019-107386
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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