MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNK CEMENT RESTRICTOR/PLUG; CEMENT ACCESSORY

Catalog Number UNK CEMENT RESTRICTOR/PLUG

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hematoma (1884); Pulmonary Edema (2020); No Code Available (3191)

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.

Event Description

"femoral impaction allografting for significant bone loss in revision hip arthroplasty." was reviewed on august 8, 2018.Study pertained to 45 hips (42 patients).Implanted between 2005-2011 all hips were implanted with: biostop g bone cement restrictor.Cmw 1 gentamicin.C-stem.Unknown depuy femoral head.Results/adverse events of the study: two intra-operative femoral canal perforations.One patient superficial non-infective hematoma (required surgical evacuation).One patient had a clinical significant pe with required medical treatment.Two cases of dislocation (1 managed with closed reduction and 1 managed with revision).Four cases of non-union of a greater trochanter.Four cases of leg length discrepancy.Twenty-eight cases of stem subsidence at 1 year post op (no revisions) subsidence ranged from 0.1mm to 6mm).

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Used to capture absence of treatment.Brand name unk cement restrictor/plug.

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.H10 additional narrative: product complaint # (b)(4).Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Device history lot: null.Device history batch: null.Device history review: null.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: UNK CEMENT RESTRICTOR/PLUG
• Type of Device: CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7786258
• MDR Text Key: 117256615
• Report Number: 1818910-2018-66768
• Device Sequence Number: 1
• Product Code: DZJ
• 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,Followup,Followup
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT RESTRICTOR/PLUG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other