MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 01/01/2017

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 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 unrelated to the index surgery.There were 12 revisions, including 3 of the liner and femoral head because of excessive polyethylene wear, 6 dues 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, it is the use of a charnley elite size 2 for all patients leading to under sizing in some patients and causing the stem to fracture.There were 6 hips with dislocations.% were treated with closed reduction, one was revised 8 years after index ths 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 16 will capture the specific adverse events associate with specific patients noted in table ii and table vii within the study.Please link all 16 additional pc-s to the parent (b)(4).(b)(6) yo female.Revised liner and head due to polyethylene wear 9.6 years after index tha.

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 # (b)(4).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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9107906
• MDR Text Key: 164081263
• Report Number: 1818910-2019-105707
• Device Sequence Number: 1
• Product Code: KWZ
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR