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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Unintended Movement (3026); Migration (4003)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 01/30/2020

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

The literature article entitled, "survivorship and radiological analysis of a monoblock, hydroxyapatite-coated titanium stem in revision hip arthroplasty" written by paul r.J.Saunders, msc, bsc, debbie a.Shaw, bsc (medsci), mbchb, frcs tr & orth, sijin k.Sidharthan, mch, ms, mbbs, paul d.Siney, ba, stephen k.Young, frsc(orth), and tim n.Board, frcs(orth), msc(ortheng), md published by the journal of arthroplasty accepted by publisher 30 january 2020 was reviewed.The article's purpose: "to determine the survivorship and incidence of intraoperative and postoperative complications with a monoblock, fully hydroxyapatite (ha)-coated femoral stem in revision hip arthroplasty (single stem design).The secondary aim is to evaluate the conservative approach rationale of proximal bone loading, reduced thigh pain, and provision of bone stock in cases of re-revision." data was compiled from 254 procedures with depuy femoral stems used in revision hip arthroplasty and original implants are not identified.The article focuses on the femoral stem and does not identify any other components.A total of 21 required re-revision of which 13 were involved the femoral stem.The other 8 cases were due to unidentified acetabular components including aseptic loosening (qty 5) and dislocations (qty 3).This pc captures adverse events associated with the identified stem.Table 2 provides patient identifiers and clarity of each case for re-revision reasons.Figure 4 provides radiographic images for progressive capture of bone remodeling of a single case.Depuy product: corail revision stem (fully ha coated) generalized adverse events: radiographic detection of bone remodeling (no interventions), radiographic detection of subsidence (no interventions required), intraoperative fractures (treated with cerclage wiring), post-operative periprosthetic fractures (article reports all fractures were associated with falls).Adverse events with patient identifiers: case 1, female, (b)(6) years old, re-revised for infection 29 months post initial revision with no measure radiographic detection of subsidence prior to re-revision case 2, female, (b)(6) years old, re-revised for infection 40 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 3, male, (b)(6) years old, re-revised for infection 43 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 4, male, (b)(6) years old, re-revised for infection 18 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 5, female, (b)(6) years old, re-revised for periprosthetic fracture associated with fall 13 months post initial revision with no measured radiographic detection of subsidence prior to re-revision case 6, male, (b)(6) years old, re-revised for periprosthetic fracture associated with fall 5 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 7, male, (b)(6) years old, re-revised for periprosthetic fracture associated with fall 10 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 8, male, (b)(6) years old, re-revised for periprosthetic fracture associated with fall 29 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 9, female, (b)(6) years old, re-revised for aseptic stem loosening 34 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 10, male, (b)(6) years old, re-revised for aseptic stem loosening 96 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 11, male, (b)(6) years old, re-revised for aseptic stem loosening 90 months post initial revision with radiographic detection of 5-10 mm subsidence prior to re-revision case 12, female, (b)(6) years old, re-revised for extended trochanteric osteotomy non-union 19 months post initial revision with radiographic detection of less than 5 mm subsidence prior to re-revision case 13, male, (b)(6) years old, re-revised for stem fracture 28 months post initial revision with no measure radiographic detection of subsidence prior to re-revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : 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.

• 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
• MDR Report Key: 10150155
• MDR Text Key: 197563007
• Report Number: 1818910-2020-13751
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention