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 Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

Event Type  malfunction  

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.(b)(4).

Event Description

Literature article entitled, ¿vitamin-e diffused highly cross-linked polyethylene liner compared to standard liners in total hip arthroplasty.A randomized, controlled trial¿ by mats salemyr, et al, published by international orthopaedics (2015), vol.39, pp.1499-1505, was reviewed.The purpose of this article was to compare the femoral head penetration wear rate of a competitor vitamin e infused polyethylene liner with a depuy marathon hxlpe polyethylene liner.The authors used dxa and other radiographic studies over a 24-month follow-up.The patient cohort used in this study has been previously reported in (b)(4).In the previous article the authors reported on the long-term efficacy of the proxima femoral stem.In this article, the authors report their study results comparing polyethylene liners.This complaint will capture the events that have not been reported in (b)(4).Implanted depuy products: pinnacle cup, marathon polyethylene liner, cocr femoral head, proxima ultrashort femoral stem.The control group was implanted with competitor tha components.Results not previously reported: 1 stem revision for deep femoral infection and associated pain.The authors discovered a higher rate of polyethylene wear in the marathon liner than in the competitor product control group.The wear was identified on serial radiographic studies and dxa scan.There was evidence of femoral head penetration and progressive wear.There were no revisions or interventions associated with the identified polyethylene wear, nor was it confirmed intraoperatively.Captured in this complaint: pinnacle cup, marathon liner, metal head, and proxima stem.

• 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
• 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: 9329695
• MDR Text Key: 191747597
• Report Number: 1818910-2019-116482
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/15/2019
• 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