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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 01/01/2002

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, "the effect of partial or full weight bearing ambulation after cementless total hip arthroplasty" by steven t.Woolson, md and neil s.Adler, pa published by the journal of arthroplasty vol.17 no.7 2002 doi:10.1054/arth.2002.34809 was reviewed for mdv reportability.The article's purpose was to compare outcomes for patients who were either partial or full weigh bearing ambulation post tha.Data was derived from 50 hips with one of the femoral components a depuy solution fully porous-cated stem and the reaming 49 were 5/8 porous-coated aml stems between october 1990 to october 1996 with 25 hips in partial weight bearing group and 25 hips in full weight bearing group.Forty-six hips had titanium beaded porous coating depuy duraloc acetabular cups and 31 polyethylene acetabular liners were composed of depuy hylamer.The remainder were made of standard high-density polyethylene (product name not provided).The article reports: "no patient required revision surgery for failure of any component.Three patients in the partial weight bearing group had a reoperation for treatment of a trochanteric nonunion in 3 hips and for removal of trochanteric wires in 1 hip." it is noted that radiologic images showed evidence of subsidence for a total of 7 patients (1-3 mm) with 1 showing an incomplete bony pedestal at the tip of the stem possibly indicating loosening; 12 femoral components had spot welds, 5 had "significant proximal femoral stress shielding evidenced by generalized osteoporosis of the femur and thinning of the proximal femoral cortices.11 hips showed hypertrophy of the femoral cortex at the distal porion of the femoral stem.2 had proximal femoral lysis involved only the grater trochanter; acetabular lysis was seen in only 1 hip.3 patients with osteolysis had a hylamer polyethylene acetabular liner.Of the femoral components, 44% were extremely tight on insertion as evidenced by the fact that they could not be inserted completely because collar-calcar contact was not seen on the postoperative radiographs." no interventions were provided for noted adverse events.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.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 STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9071801
• MDR Text Key: 206012918
• Report Number: 1818910-2019-104578
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1