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

Catalog Number UNK HIP FEMORAL AUGMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Injury (2348); Impaired Healing (2378); No Code Available (3191)

Event Date 04/17/2017

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

The literature article entitled, "clinical study of applying s-rom femoral prosthesis in hip joint revision" written by shang piao, yonggang zhou, yinqiao du, haiyang ma, jingyang sun, zhisen gao, yawen peng, and wenming wu published by china orthopaedic trauma, april 2017, volume 30, no 4 was reviewed for mdr reportability.The purpose of the study is to discuss the mid-term clinical efficacy of applying s-rom femoral prosthesis in hip joint revision for femoral reconstruction.The data was complied from 21 patients (21 hips) receiving hip joint revision between january 2008 and january 2016 with follow up range of 12-97 months.A number of patients received the following depuy products: pinnacle cup (8 patients), duraloc cup (2 patients) and reinforcement ring (4 patients); all patients received s-rom stem; bearing surfaces were cop (6 patients) and coc (15 patients).Others received non-depuy products indicating patients received a mixture of products within their revision surgeries.The article reveals 2 patients with identifiers with adverse events which are captured in linked complaints.Article does not provide adequate information to determine accurate quantity numbers of affected products.This complaint captures the adverse events without patient identifiers: 4 intra-operative proximal femoral fractures treated with wiring (1 patients), binding belt (2 patients), and cable ready plate (1 patient); non-union incision treated with local debridement; bone stress shielding without impact to function and no loosening (4 patients).

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.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL AUGMENT
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9187714
• MDR Text Key: 173020442
• Report Number: 1818910-2019-109040
• Device Sequence Number: 1
• Product Code: KWA
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL AUGMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention