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); No Code Available (3191)

Event Date 04/23/2013

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 "a modified s-rom stem in primary total hip arthroplasty for developmental dysplasia of the hip" written by hideaki tamegai, md, takuya otani, md, phd, hideki fujii, md, phd, yasuhiko kawaguchi, md, tetsuo hayama, md, and keishi marumo, md, phd published by the journal of arthroplasty 28 (2013) 1741-1745 accepted 23 april 2013 was reviewed.The article's purpose was to examine short term outcome of asians who underwent primary tha for treatment of ddh using the s-rom-a stem.The data was compiled from 220 hips of 196 patients (195 females and 25 males with mean age of 61.7 years) with a mean follow up of 40 months.Adverse events noted: longitudinal fracture of the femur around the sleeve intraoperatively (3) and successfully treated by wiring, post operative dislocation (2), revision due to pseudarthrosis at the osteotomy site and received bone grafting followed by bone union (1).The article does not identify any femoral head but an illustration in figure 1 provides an example with femoral head applied leading reviewer to reasonably conclude that at least the femoral head was also a depuy product.

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: 9232783
• MDR Text Key: 176952907
• Report Number: 1818910-2019-111740
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention