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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)

Event Date 02/10/2008

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, "dislocation of an s-rom total hip arthroplasty secondary to traumatic femoral stem dissociation from the metaphyseal sleeve" written by david w.Fabi, md, wayne m.Goldstein, md, and alexander c.Gordon, md published by the journal of arthroplasty vol.24 no.1 2009 accepted by publisher 10 february 2008.The article's purpose was to report on a case of a femoral stem and metaphyseal sleeve dissociation.The case was a (b)(6) female with left tha implanted with srom modular hip system.Medical comorbidities include hypertension, rheumatoid arthritis, hypothyroidism, and diabetes mellitus.She experienced a fall with negative radiographic findings for fracture or dislocation.She continued to experience left groin pain and left lateral proximal femur and continued negative findings in radiographic images so was diagnosed with muscle strain.Then she experienced a dislocation and was treated with closed reduction, abduction brace and physical therapy.She then experienced another dislocation and it was decided for revision to be performed.The plan was to replace the acetabular component and femoral head component with larger sizes but intraoperative findings revealed the stem to be retroverted and slightly loose.The sleeve was well fixed.Stem was removed and inner portion of sleeve was irrigated cleaned.Surgeon planned to implant a longer stem but one was not available during operation so surgeon placed a distal medullary canal plug, miig was injected in a retrograde fashion and new stem of the same dimension was reinserted.The patient did not experience any further complications and recovered well.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthes 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 associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Patient code 3189, used to capture 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
• MDR Report Key: 9395796
• MDR Text Key: 185083334
• Report Number: 1818910-2019-118670
• 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: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• 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
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention