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 (4003)

Patient Problems Pulmonary Embolism (1498); Bone Fracture(s) (1870); Pain (1994); Thrombosis (2100); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.(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, ¿cemented charnley revision arthroplasty for severe femoral osteolysis¿ by v.V.Raut, et al, published by the journal of bone and joint surgery (1995), vol.77-b, pp.362-365, was reviewed for mdr reportability.The authors reviewed prospectively cemented stem revision in 106 patients with severe femoral endosteal bone lysis without infection implanted with the charnley tha from 1997-1990.Femoral heads are unspecified.Results: charnley became a depuy product in 1990.This complaint captures all reported complications and revisions from 1977-1990 because the authors do not specify when the complications occurred.10 femur fractures.5 stem migrations requiring revision.13 cup and head revisions due to loosening and osteolysis.7 re-revisions of stem and cup for loosening (6), femur fracture (1), and unexplained pain (1).17 cases of osteolysis of the acetabulum and femur.Complications: 3 calcar fractures intraoperatively.1 femur perforation intraoperatively.2 trochanter fractures.3 dislocations.10 non-union of the trochanters requiring revision.4 pulmonary emboli.3 unspecified abdominal complications.3 unspecified cardiovascular complications.3 deep vein thrombi.2 delayed wound healing.It is unknown how many of these complications and revisions are attributed to depuy products.The article does not provide enough information to identify time of each occurrence.Additionally, the authors do not provide the manufacturer of the bone cement or restrictor used.This complaint captures all complications and interventions.The abdominal and cardiovascular complications are unspecified.There is not enough information to include these within the complaint.".

• 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): 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: 9220448
• MDR Text Key: 176392986
• Report Number: 1818910-2019-108700
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• 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