MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Loss of or Failure to Bond (1068); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

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, "no added value for computer-assisted surgery to improve femoral component positioning and patient reported outcomes in hip resurfacing arthroplasty; a multi-center randomized controlled trial" written by m.C.Koper, m.Reijman, e.M.Van es, j.H.Waarsing, h.W.J.Koot, s.B.Keizer, i.Janesen, f.C.Van biezen, j.A.N.Verhaar, and p.K.Box published by bmc musculoskeletal disorders in 2019 was reviewed.The article's purpose was to compare femoral component positioning between cas (computer assisted surgery) and manual placement in a multi-center, patient-blinded, randomized controlled trial.All patients received depuy asr implants and the cement manufacturer is not identified.Data was compiled from 125 patients (133 hips) with 67 hips in the manual placement 66 hips in the cas group.The article provides details for the 11 total revisions in table 5 with patient identifiers, and the article reports all revision cases were managed with total hip arthroplasty.Figure 1 provides radiographic images for illustrative purposes and does not indicate any adverse events within caption description.Depuy implants: asr cup, asr femoral head: early complications and generalized adverse events: one patient with minor cardiac ischemia (no treatment indicated and no further information provided).One patient complained of painful lower leg and swelling but thrombosis was excluded (no treatment indicated and no further information provided).One patient had superficial skin infection (treated with oral antibiotics and resolved without further problems).Revisions in cas group: case 1 - (b)(6) years old female with 46 mm size component revised for collum fracture 3 months post primary and received revision to femoral component.Case 2 - (b)(6) years old male with 49 mm size component revised for collum fracture 25 months post primary and received revision to femoral component.Case 3 - (b)(6) years old male with 53 mm size component revised for armd and high cobalt/chromium 29 months post primary and received revision to femoral and acetabular components.Case 4 - (b)(6) years old female with 47 mm size component revised for aseptic loosening 30 months post primary and received revision to femoral and acetabular components.Case 5 - (b)(6) years old female with 46 mm size component revised for collum fracture 1.5 months post primary and received revision to femoral component.Revisions in manual placement group: case 6 - (b)(6) years old male with 49 mm size component revised for pain 25 months post primary and received revision to femoral component.Case 7 - (b)(6) years old female with 45 mm size component revised for aseptic loosening 8 months post primary and received revision to femoral and acetabular components.Case 8 - (b)(6) years old female with 43 mm size component revised for aseptic loosening 21 months post primary and received revision to femoral and acetabular components.Case 9 - (b)(6) years old male with 51 mm size component revised for pain and high cobalt/chromium 21 months post primary and received revision to femoral and acetabular components.Case 10 - (b)(6) years old female with 41 mm size component revised for altr and high cobalt/chromium 22 months post primary and received revision to femoral and acetabular components.Case 11 - (b)(6) years old male with 51 mm size component revised for aseptic loosening.5 months post primary and received revision to acetabular component.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in (b)(6) 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa-001226.Ongoing post market surveillance is conducted per our procedures for this product.H10 additional narrative:  corrected: h6 (device).

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10274507
• MDR Text Key: 208203404
• Report Number: 1818910-2020-15872
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention