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); Unspecified Infection (1930); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 01/01/2008

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, "conversion of failed hemiarthroplasty to total hip arthroplasty: a short to mid-term follow-up study" written by amite pankaj, rajesh malhotra, and surya bhan published by indian journal of orthopaedics 2008 jul-sep; 42(3): 294¿300 doi: 10.4103/0019-5413.41852 in 2008 was reviewed for mdr reportability.The article reports on 30 women and 14 men who had failed hemiarthroplasties and was converted to tha.Only 2 patients received depuy s-rom during their conversion operations with no identification of femoral head or acetabular components.Generalized reported adverse events of the entire study for 44 patients: intraoperative femur fracture treated with cerclage wiring and delayed weight bearing (6), acetabular floor fractures intraoperatively treated with delayed weight-bearing (3), infection requiring intravenous antibiotic therapy (3), dislocation reduced by closed manipulation under anesthesia occurring on the 3rd post operative day with patient wearing abduction brace for 3 months without reoccurrence (1), myocardial infarction (1), chest infection (1), uti (1), dvt (2).No death was encountered in the study group that could be directly attributed to the surgery or its complications.The article does not identify which adverse events are associated with depuy products if any.

Manufacturer Narrative

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, 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 9164919
• MDR Text Key: 169455166
• Report Number: 1818910-2019-107921
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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 AUGMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention