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); Pain (1994); Joint Dislocation (2374); Post Operative Wound Infection (2446); No Code Available (3191)

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.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).

Event Description

"literature article abstract entitled, ¿long-term results of aml porous prostheses used in primary total hip arthroplasty¿ by vaquero martín, j.Et al, published by orthopaedic traumatology (2002), vol.1, pp.20-25, was reviewed.The purpose of this article was to determine the long-term reliability of the aml total hip arthroplasties implanted between april 1988 and december 1990.Implanted depuy products: aml cup, aml stem, and depuy liner and head.Some cases were implanted with an unknown acetabular ring.Results: 6 local wound infections treated with antibiotics 2 hematomas- treatment unknown 4 dislocations- 3 treated with closed reductions and one treated open reduction 2 cup migrations treated with revision 1 case of pain, stem loosening and migration due to inadequate osseointegration treated with revision 5 cases of polyethylene wear treated with revision unspecified number of mispositioned cups and stems unspecified number of patients had postoperative walking difficulty 1 intraoperative femoral fracture treated with an unknown screw captured in this complaint: aml cup: implant migration, implant mispositioned.Acetabular liner: implant bearing wear, implant dislocation.Femoral head: implant dislocation.Aml stem: implant mispositioned, implant loosening.Patient harms: infection, hematoma, joint dislocation, walking difficulty, inadequate osseointegration, pain.".

• 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
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9400900
• MDR Text Key: 184814678
• Report Number: 1818910-2019-119454
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 11/08/2019

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: 11/08/2019
• Initial Date FDA Received: 12/03/2019
• 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