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 Hematoma (1884); Unspecified Infection (1930); Joint Dislocation (2374); No Code Available (3191)

Event Date 10/21/2013

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.(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, ¿dual mobility cup reduces dislocation and re-operation when used to treat displaced femoral neck fractures¿ by anne s.Bensen, et al, published by international orthopaedics (2014), vol.38, pp.1241-1245, was reviewed.The aim of this study is to compare rates of dislocation and re-operation of any kind following treatment for displaced femoral neck fractures with either bipolar ha or tha with dual mobility cups.In 2007¿2008 171 patients were treated with bipolar ha.In 2009¿ 2010 175 patients were treated with tha with dmc.Data regarding rates of dislocation and re-operation were obtained by retrospective review of medical records.Depuy products: cemented and cementless corail stems and bipolar heads were used in the ha.Competitor heads, liners, and cups were paired with corail stems in the tha group.A total of 9 corail stems were cemented and 166 were cementless.The manufacturer of the cement is unknown.Results: 21 ha dislocations treated with revision to tha or conversion to girdlestone 10 total periprosthetic stem fractures- 3 treated surgically.All stems were cementless 3 loosened stems.It is unknown if the stems were cemented or cementless.Treatment unknown.Coded for implant loosening of an unknown interface.9 deep infections- treated with surgical intervention 1 postoperative hematoma in the tha group- applicable to stem only 23 ha were revised to thas, reasons unspecified 2 has were converted to girdlestone, reasons unspecified 9 thas were revised, components revised are unspecified captured in this complaint: corail stem, bipolar head.

• 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
• 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: 9343068
• MDR Text Key: 185054545
• Report Number: 1818910-2019-114701
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 10/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/19/2019
• 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