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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Thrombosis (2100)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

An article was received entitled ¿highly cross-linked polyethylene reduces wear and revision rates in total hip arthroplasty¿.Literature article entitled, ¿highly cross-linked polyethylene reduces wear and revision rates in total hip arthroplasty a 10-year double-blinded randomized controlled trial¿ by peter a.Devane, mbchb, msc, fracs, et al, published by the journal of bone and joint surgery (2017), vol.99, pp.1703-1714 was reviewed for mdr reportability.The purpose of this study was to compare, in a double blinded randomized controlled trial with a minimum of 10 years of follow-up, the wear rates and clinical results of standard uhmwpe and xlpe using identical implant designs and fixation methods.We hypothesized that xlpe would be associated with less in vivo wear than conventional uhmwpe at 10 years following primary hip arthroplasty and that this would be associated with lower rates of osteolysis and improved prosthetic survival.An uncemented shell (duraloc sector; depuy) augmented with two 6.5-mm cancellous screws was used after under reaming by 1 mm to achieve initial press-fit.All patients received a charnley elite size-2 round back cemented femoral stem (depuy), a 28-mm cobalt-chromium femoral head (articul/eze; depuy), and a 28-mm inner-diameter polyethylene liner- either enduron or marathon.All patients were accounted for at the final follow-up.The authors observed no significant difference between the marathon (xlpe) and enduron (uhmwpe) groups with respect to age, sex, operative side, surgeon, cup size, or cup positioning (anteversion or abduction angle).Osteolysis was observed in 20 hips, and there was a significant difference in the prevalence between the 2 groups (16 [38%] of 42 in the enduron group and 4 [8%] of 49 in the marathon group.Postoperative complications included a nonfatal pulmonary embolus secondary to a deep venous thrombosis in 1 patient (marathon group) and a deep infection at 4 weeks treated with irrigation and debridement without exchange of the enduron liner in another.There were 6 dislocations, all occurring in patients in whom the posterior approach had been used.At the time of the latest follow-up, 21 patients had died (mean age at surgery, 67.2 years; range, 52 to 75 years); 12 of these patients had an enduron liner and 9, a marathon liner.All deaths, which occurred at a mean of 6.2 years (range, 0.7 to 10.3 years) postoperatively, were considered to be unrelated to the index surgery.There were 12 revisions, including 3 of the liner and femoral head because of excessive polyethylene wear, 6 due to femoral osteolysis or aseptic loosening of the stem, and 3 due to stem fracture (table iii).Ten of the revisions were performed in the enduron group and the other 2 (due to stem loosening caused by stem fracture in 1 and by cement mantle revisions were undertaken as a result of loosening of the acetabular shell.Patients with an enduron liner had a significantly higher revision rate than those with a marathon liner (fig.9; log-rank chi-square test (1 degree of freedom [df]) = 6.3; p = 0.012), with the first revisions seen after just 5 years.The patients treated with the enduron liner had a significantly higher prevalence of osteolysis.The 3 stem fractures were a fault of the study design, ith the use of a charnley elite size 2 for all patients leading to undersizing in some patients and causing the stem to fracture.There were 6 hips with dislocations.All were treated with closed reduction, one was revised 8 years after index tha for osteolysis.This complaint will have a total of 17 pcs.The parent pc will include perioperative complications associated with the implants.Case 1-case 18 will capture the specific adverse events associate with specific patients noted in table ii and table vii within the study.Please link all 18 additional pc-s to the parent (b)(4).

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.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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9109890
• MDR Text Key: 164610034
• Report Number: 1818910-2019-105859
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• 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 STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention