MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 09/09/2011

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.

Event Description

Literature article entitled "the effect of poly sterilization on wear, osteolysis and survivorship of a press-fit cup at 10-year followup".Literature article entitled, ¿the effect of poly sterilization on wear, osteolysis and survivorship of a press-fit cup at 10-year follow-up¿ by charles a.Engh, md, et al, published by clinical orthopaedics related research (2012), vol.470, pp.462-470 was reviewed for mdr reportability.The purpose of this article was to determine whether the fixation of an acetabular component achieved by solely relying on a press-fit would be durable and how different liner sterilization methods affected radiographic wear, osteolysis, and survivorship.The authors retrospectively reviewed 373 patients who underwent 398 primary thas with a press-fit porous-coated cup between march 1995 and december 1996.Mean age at time of surgery was 61.5 ± 13.3 years and mean follow-up was 10.4 ± 3.7 years.373 patients who had 398 primary thas using duraloc 100 cups coupled with prodigy or aml stems between march 1, 1995, and december 31, 1996.The components were sterilized using one of three methods: gamma irradiation in air (gamma-air), gamma irradiation with barrier packaging without oxygen (gamma-barrier), and gas plasma.The stems used were 229 prodigy stems and 169 aml stems.The liners were 352 enduron and 46 hylamer.298 cocr heads and 100 ceramic femoral heads were implanted.The authors identified 20 thas that had undergone component revisions.None of the thas with higher crystallinity (hylamer tm) liners have been revised.Revisions for complications associated with wear and osteolysis began to occur 7.2 years after surgery and have included six liner exchanges and one cup revision performed at an outside institution.16 of the revisions were limited to liner exchanges.Only one femoral component was removed during a complete revision for infection.Since no component has been revised for loosening and none of the primary tha components retained during a revision surgery subsequently loosened, cup and stem survivorship, using revision for aseptic loosening as an end point, were both 100% at 10 years.Among 185 unrevised thas with minimum 10-year radiographs (mean, 12.3 ± 0.8 years; range, 10.1¿14.4 years), none of the cups were graded as definitely loose or fibrous stable.Among the stems, 184 were bone ingrown and one was loose.Osteolysis was noted among 48% (89 of 185) of the thas, and the mean combined size of the pelvic and femoral lesions in these hips was 2.9 ± 3.6 cm2 (range, 0.04¿15.1 cm2).Considered separately, the incidence of osteolysis was 31% (57 of 185) for the pelvis and 31% (58 of 185) for the femur.In this study, the absence of cup loosening, despite a 31% (57 of 185) incidence of pelvis osteolysis, may be explained by a previous finding that the surface area of the cup occupied by osteolysis plateaued at 40% despite progressively increasing lesions sizes.The combination of a press-fit duraloc 100 cup without supplemental fixation and an extensively porous-coated stem demonstrated durable implant fixation even in the presence of osteolysis.

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 #
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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.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. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9078507
• MDR Text Key: 162972467
• Report Number: 1818910-2019-105007
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• 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: 09/17/2019
• 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: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention