MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK REAMER; HIP INSTRUMENT

Catalog Number UNK REAMER

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); 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.Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4).

Event Description

Literature article entitled, ¿fracture of uncemented revision femoral stems in three arthroplasty patients: a case series with three different brands¿ by rajiv merchant, et al, published by the journal of orthopedic case reports (2014), vol.4, no.4, pp.12-15, was reviewed for mdr reportability.The authors report 3 cases of uncemented revision stem fractures.Case 1 is a (b)(6) year-old male and cases 2 and 3 are patients implanted with competitor products.A (b)(6) year-old gentleman had a right total hip arthroplasty done in 1998 and subsequently underwent a revision in 2004 of both the femoral and acetabular components for instability and failed prosthesis.An extended trochanteric osteotomy was used to extract the femoral stem which was replaced with a cementless bowed solution¿ stem (depuy) sized 13.5 mm.The trochanteric osteotomy was reattached with two dall-miles¿ cables.4 years later with he presented the emergency department with deteriorating groin pain in the absence of trauma.His radiograph showed an extensive proximal osteolysis and a transverse fracture at the junction of the proximal and middle third of the stem.His re-revision surgery consisted of a proximal femoral osteotomy to remove proximal end of the stem with care.The stem was replaced with a 16mm reef¿ prosthesis (depuy).The reaming caused a vancouver c type periprosthetic fracture and was treated with a dall-miles cable plate.The eto was repaired using dall- miles cables.The patient had an uneventful course to recovery.The post-operative xray was taken at the patients last outpatient visit prior to discharge at a time period of 2 years post-surgery.Patient was ambulating with a walking stick.There was no revision done of the acetabular components.

Manufacturer Narrative

Product complaint #: (b)(4).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.

• Brand Name: UNK REAMER
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9163244
• MDR Text Key: 168466747
• Report Number: 1818910-2019-107131
• Device Sequence Number: 1
• Product Code: LXH
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK REAMER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention