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 No Consequences Or Impact To Patient (2199)

Event Date 08/21/2009

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.(b)(4).

Event Description

The literature article entitled, "ultra-short anatomic uncemented femoral stem and ceramic-on-ceramic bearing in patients with idiopathic or ethanol-induced femoral head osteonecrosis" written by young-hoo kim, md and jang-won park, md published by the journal of arthroplasty accepted by publisher 21 august 2009 was reviewed.The article's purpose was "to evaluate the long-term clinical outcomes using validated scoring instruments; radiographic results; computed tomography (ct) scan results to determine osteolysis; dual-energy x-ray absorptiometry (dexa) scanning results to determine bone remodeling; complication rates; revision rate and osteolysis; and survivorship of the femoral stem in patients with idiopathic or ethanol-induced femoral head osteonecrosis." data was compiled from 256 patients (335 hips) including 140 men and 116 women with an average age at the time of surgery of 49.8 (range 20-63 years).All implants were depuy products.The article does not provide which platforms of cups were associated with specific adverse events.It is noted that a radiographic image is provided for a 45 year old man as an example of well fixated implants.The image notes some calcar resportion but "bone stock is well preserved without stress-shielding-related osteopenia." depuy products utilized: duraloc and pinnacle cups, proxima stems, coc bearings.Adverse events: clicking or squeaking sounds (interventions unknown), dislocations (treated by closed reductions and revision), femoral loosening (treated by revision), cup loosening (treated by revision), mispositioned cups and mispositioned stems (article reports they were radiographic detections but not revised), femoral fx post op (radiographically discovered after a fall and treated with orif), pain associated with loose stem along with difficulty walking.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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).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
• MDR Report Key: 9466638
• MDR Text Key: 191285904
• Report Number: 1818910-2019-120564
• Device Sequence Number: 1
• Product Code: KXA
• 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: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1