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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Loss of Osseointegration (2408); Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

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, a follow-up medwatch will be filed as appropriate.

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

"literature article entitled, ¿impaction bone-grafting of severely defective femora in revision total hip surgery: 21 hips followed for 41-85 months¿ by frans c.Van biezen, et al, published by acta orthopaedica scandinavia (2000), vol.71, no.2, pp.135-142, was reviewed.The purpose of this article was to review the efficacy of femoral impaction bone grafting in thas for patients with severe bone defects implanted between september 1992-september 1995.The authors used competitor and depuy tha components.This complaint captures the individual results for patients implanted with cemented depuy charnley products.The cement utilized is unknown.The manufacturer of the components used in revision are unknown.Patient 4: (b)(6) female.Charnley stem revised due to periprosthetic fracture, stem loosening of an unknown interface, and stem migration.Patient 7: (b)(6) female.Revised charnley stem due to pain, stem loosening of an unknown interface, and stem migration secondary to non-union of the femoral osteotomy site (bone injury).Patient 8: (b)(6) female.Revised charnley stem due to pain and stem loosening of an unknown interface.Patient 12: (b)(6) female.Revised charnley stem due to pain and stem migration secondary to loosening of the stem.Patient 20: (b)(6) male patient.Revised charnley stem due to pain, stem loosening of an unknown interface, and 4-mm stem migration.Patient 21: (b)(6) female.Revised charnley stem due to pain, periprosthetic femoral fracture, stem loosening of an unknown interface, and 3-mm stem migration.Patient 16: (b)(6) female.Patient experienced a dislocation of a charnley cup and a competitor femoral head.Treatment for the dislocation is unknown.".

• 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9654712
• MDR Text Key: 186456025
• Report Number: 1818910-2020-03720
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 02/05/2020
• 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
• Patient Age: 41 YR