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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 04/30/2001

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.(b)(4).

Event Description

Literature article entitled, " failure of hydroxyapatite-coated acetabular cups".Literature article entitled, ¿failure of hydroxyapatite-coated acetabular cups: ten-year follow-up of 85 landos atoll arthroplasties¿ by kuo-an lai, et al, published by the journal of bone and joint surgery (2002), vol.84-b, no.5, pp.641-646 was reviewed for mdr reportability.Between march 1990 and may 1991, the authors performed 85 primary total hip replacements in 74 patients using the landos atoll hydroxyapatite (ha)-coated cup and the corail ha-coated stem.The patients were followed up for a mean of ten years.Of the 85 cups, 26 (31%) have already been revised and a further six are radiologically unstable and awaiting revision.Two femoral stems have been revised for infection without loosening.There were 29 women (33 hips) and 45 men (52 hips) with a mean age of 50.2 years (29 to 71).The diagnosis was osteonecrosis of the femoral head in 33, primary osteoarthritis in 18, post-traumatic arthritis in 12, arthritis secondary to acetabular dysplasia in nine, ankylosing spondylitis in four, previous hip sepsis in four, rheumatoid arthritis in three, and psoriatic arthropathy in two.The acetabulum was under-reamed by 2 mm and the cup was inserted using the press-fit method.Between three and five screws were inserted for primary fixation.The size of the cup ranged from 48 mm to 54 mm.In none was the thickness of the polyethylene insert less than 5 mm.All heads were 32 mm; 20 were ceramic and 65 stainless steel.The femoral stem was also inserted according to the press-fit principle without cement.At the latest review 49 hips in 45 patients were still in place.Four patients (six hips) had died from unrelated causes, 22 (26 hips) had a revision and three (four hips) had been lost to follow-up.The harris hip score at follow-up at two years was excellent, but because of progressive loosening of the cup at follow-up at five and eight years and at the latest review it was lower than at two years.This was also true of the pain score, but the number of patients with thigh pain remained low.Septic loosening in six hips, aseptic loosening in 14, polyethylene wear in five and osteolysis in one.The four patients (6 hips) with sepsis were immunocompromised, the underlying diseases being rheumatoid arthritis, systemic lupus erythematosus, psoriasis and ankylosing spondylitis.The infections were all late in onset, presumably hematogenous, and occurred at a mean of 76 months (67 to 84) after operation.These patients underwent two-stage reimplantation.In four the stem was not revised.There was no recurrence of infection during the follow-up period.A further six cups were clinically loose and are awaiting revision at the latest follow-up.Of the 26 cups with radiological loosening, 24 had migrated into varus and two had migrated centrally.Of the 20 hips with biolox (ceramic) heads, four were loose (20%).Of the 65 with inox (stainless-steel) heads, 16 were loose (24.6%).The head loosening not the stem revisions were not indicated within the specific patient information located in table ii, page 644.This complaint will have 27 pcs.The parent (b)(4) and 26 additional pcs labeled cases 1-26.

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).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.Device history lot : null.Device history batch : null.Device history review : null.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
• MDR Report Key: 9109785
• MDR Text Key: 164615440
• Report Number: 1818910-2019-105870
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention