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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Unspecified Infection (1930); Pain (1994); Joint Dislocation (2374)

Event Date 11/24/2013

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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, "early outcome comparison between the direct anterior approach and the mini-incision posterior approach for primary total hip arthroplasty: 150 consecutive cases" written by mark w.Zawadsky, md, megan c.Paulus, md, patrick j.Murray, md, and matthew a.Johansen, md published by the journal of arthroplasty 29 (2014) 1256¿1260 accepted by publisher 24 november 2013 was reviewed.The article's purpose was to address criticisms of minimally invasive technique of anterior approach for thas verses posterior approach technique by reporting on results of 150 consecutive cases.All patients received the same implants.The article focuses on a comparison of anterior approach and posterior approach techniques.It does not provide any further details on the listed complications.Depuy products utilized: pinnacle cups, trilock bps stems, cocr or ceramic heads, poly liners.Adverse events: subsidence (no clarification if progressive, confirmed surgically or any interventions), thigh pain (no information regarding interventions or patient impact), infection (no information regarding interventions, fracture (after fall - no information regarding interventions), dislocation (no information regarding intervention).The article provides no details on interventions for the adverse events and only lists them as complications in table 5 page 1259.

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).Investigation summary : 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9367530
• MDR Text Key: 220633937
• Report Number: 1818910-2019-116844
• 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
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1