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); Loss of Osseointegration (2408); Migration (4003)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 03/10/2017

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 received entitled "dual-mobility vs fixed-bearing total hip arthroplasty in patients under 55 years of age: a single-institution, matched-cohort analysis." literature article entitled, ¿dual-mobility vs fixed-bearing total hip arthroplasty in patients under 55 years of age: a single-institution, matched-cohort analysis¿ by fiachra e.Rowan, md, frcs, et al, published by the journal of arthroplasty (2017), vol.32, pp.3076-3081 was reviewed for mdr reportability.This study compared results of patients <55 years of age with dm vs fixed-bearing (fb) primary tha.An age-matched comparative analysis was performed for 136 thas using third-generation highly crosslinked polyethylene dm bearings and 136 thas using fb from the same manufacturer with mean follow-up of 3.2 and 3.4 years, respectively.The authors compared components from a variety of manufacturers, carefully ensuring that the acetabular components used in each individual were always from the same manufacturer.In the dm cohort, there were zero acetabular components from depuy and 4 s-rom femoral stems implanted.In the fb cohort, there were 20 pinnacle acetabular components using either a ceramic or polyethylene liner and a variety of ceramic or metal alloy femoral heads.The fb cohort has 2 s-rom modular and 20 tri-lock bps femoral stems.In the dm group, there were no dislocations and no intraprosthetic dissociations at 3-year mean follow-up; however, there were 7 patients (5.1%) in the fb group who dislocated.There were no revisions in the dm cohort for instability.In the fb cohort, 2 of the 7 patients with instability were revised for recurrent instability.In the fb cohort, there were no revisions for aseptic loosening or fracture.The dm cohort, two stems were revised for aseptic loosening.The first case demonstrated early subsidence of a distally fluted, proximally coated fit-and-fill stem at 6 weeks postoperatively.The patient presented with thigh pain and inability to weight bear.The cause of subsidence was technical error and implantation of an undersized stem.A modular tapered, diaphyseal engaging, titanium alloy revision stem was implanted with good stability, bony ingrowth, and subsequent resolution of patient symptoms.The second case of femoral stem aseptic loosening occurred in a patient with hip dysplasia and significant proximal femoral dysplasia that required trochanteric osteotomy.A modular, metaphyseal-bearing titanium alloy stem and trochanteric hook plate were used to restore hip center of rotation and repair the osteotomy.The metaphyseal device failed to in-grow, and there was trochanteric escape.The stem was revised to a fully coated cylindrical cocr alloy stem which has remained stable.The plate was also revised; however, the trochanter demonstrated chronic nonunion at latest follow-up.The authors do not provide detail regarding the specific products causing revisions in the fb cohort or the femoral revisions in the dm cohort.There is specific patient detail with regards to the fb dislocations- though does not identify the product or manufacturer- located in table 3 on page 3079 of the text.These seven patients will have individual complaints linked to this complaint.There was one periprosthetic acetabular fracture revision in the dm cohort that is related to products from another manufacturer.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 #
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> (b)(4).Investigation summary
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> 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.Device history lot
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> null.Device history batch
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> null.Device history review
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> null.If information is obtained that was not available for the initial medwatch, a follow-up 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: 9030636
• MDR Text Key: 159757285
• Report Number: 1818910-2019-104328
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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
• Date Manufacturer Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention