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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2020

Event Type  malfunction  

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.

Event Description

Literature article abstract entitled, ¿influence of femoral component design on proximal femoral bone mass after total hip replacement a randomized controlled trial¿ by pablo a.Slullitel, et al, published by the journal of bone and joint surgery (2020), 10 pages, was reviewed.The purpose of this randomized control trial was to compare bone remodeling and bone turnover, measured by dxa scans, in 46 trilock bps and 40 corail stems implanted between may 2013 and may 2017.The authors note that there was radiographic evidence of bone loss in the first 12 weeks postoperatively that returned to baseline within 12 weeks postoperatively.This complaint will capture the adverse events reported for 8 trilock stems and 5 corail stems.Results: 1 revision of a trilock stem to treat aseptic loosening at 96 weeks.1 report of a femoral palsy in trilock stem, treatment unknown.4 calcar cracks reported: 1 trilock and 3 corail, treatment unknown.1 deep infection with a corail stem, treatment unknown.6 reports of postoperative pain: 5 with trilock and 1 with corail.Treatment unknown.The authors report an unknown number of trilock and corail stems were identified as being in varus in postoperative radiographic studies.There is no indication if this required treatment or intervention.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the attached images could not confirm the reported complaint.A root cause could not be determined.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• 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: 10957778
• MDR Text Key: 220661658
• Report Number: 1818910-2020-26297
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• 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: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1