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 Hemorrhage/Bleeding (1888); Joint Dislocation (2374)

Event Date 11/01/2014

Event Type  Injury  

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, "surgical technique and outcome of uncemented thr using ha coated stems in fused and deformed hips due to ankylosing spondylitis" written by sundaresh dabir, sharath ramanath, harshad shah, madhukesh rudramurthy, and sanjana s.Patil published by hip int 2015; 25 (2): 142-145 doi: 10.5301/hipint.5000197 on 1 november 2014 was reviewed for mdr reportability.The article reports on patients who received uncemented porous coated depuy duraloc titanium cups with depuy marathon highly cross linked poly liner and hydroxyapatite coated depuy corail stems.A total of 4 patients had a breach in medial wall of the acetabulum during reaming and received bone grafting on the medial wall before cup insertion.One patient was noted to 56 degree inclination.One patient had a posterior dislocation of the hip and treated by closed reduction and traction applied for 3 weeks after reduction.Blood transfusion was required by 2 patients.3 patients had leg length discrepancy of.5 cm and managed with shoe rise.The article does not identify the femoral head.Adverse events: acetabular fracture receiving intraoperative treatment, mis-positioned cup, dislocation with treatment, major bleed, limb asymmetry.

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 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9164861
• MDR Text Key: 165973766
• Report Number: 1818910-2019-107950
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• 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