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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problem Hip Fracture (2349)

Event Date 01/01/2016

Event Type  Injury  

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, "mid-term outcome of total hip arthroplasty using a short stem" written by rajesh malhotra and vijay kumar published by journal of orthopaedic surgery 2016;24(3):323-7 was reviewed for mdr reportability.The article reports on 33 hips in 20 men and 10 women aged 25 to 40 years old with depuy proxima stems and depuy acetabular components of pinnacle (25) and duraloc (8) with bearings of mop (23), coc (7), and cop(3).Adverse events: one patient with stem migration (no measurement provided) leading to surgical removal and damage to proximal femoral bone during removal, one patient with leg lengthening of 1.5 cm (no clarification if intervention was provided), one patient with proximal femur fracture (diagnosed with hurler syndrome) treated with cerclage wiring (not specified if fracture occurred intraoperatively or post operatively).The article does not clarify which specific acetabular components are associated with the patients who experienced adverse events nor does it provide patient identifiers.The article does not identify bearing surfaces of for femoral head for the adverse events.

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.Product complaint # (b)(4).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, 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: 9163710
• MDR Text Key: 169235289
• Report Number: 1818910-2019-107944
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention