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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Failure to Osseointegrate (1863)

Patient Problems Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 06/26/2013

Event Type  Injury  

Manufacturer Narrative

(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.(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

"literature article entitled, ¿bacterial contamination of the wound during primary total hip and knee replacement¿ by eythor örn jonsson, et al, published by acta orthopaedica (2014), vol, 85, no.2, pp.159-164, was reviewed.The authors studied the prevalence and bacteriology of intraoperative contamination during primary joint replacement and assessed whether the presence of intraoperative contamination is related to postoperative joint infection on long-term follow-up.The authors studied tka and tha surgeries.The tka prostheses were competitor products and will not be included in this complaint.The authors collected intraoperative samples from various locations to test for different types of bacterial contamination during the surgical process and compared those results with incidences of postoperative infection.The index surgeries were performed between october 1990 and september 1991.Implanted depuy products: 49 charnley elite thas: polyethylene cemented cups, femoral head, and both cemented and cementless charnley stems.The cement used was a competitor product.Results: there were 19 cases of intraoperative bacterial contamination.None of these developed into a postoperative infection in any patient.5 revisions for aseptic loosening of unspecified components 2 revisions for unspecified joint instability.Captured in this complaint: the authors did not provide any additional information regarding the revision surgeries.Charnley cup and stem for implant loosening, joint instability.Charnley head for joint instability.Patient harms: medical device removal, inadequate osseointegration, surgical intervention, and medical device removal.".

• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9316671
• MDR Text Key: 182470199
• Report Number: 1818910-2019-115540
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2019
• 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