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 Problems Bone Fracture(s) (1870); Thrombosis (2100)

Event Date 02/09/2016

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, "medial protrusio technique in cementless total hip arthroplasty for developmental dysplasia of the hip: a prospective 6- to 9-year follow-up of 43 consecutive patients" written by guo-chun zha, md, jun-ying sun, md, kai-jin guo, md, feng-chao zhao, md, yong pang, md, and xin zheng, md published by the journal of arthroplasty 31 (2016) 1761e1766 http://dx.Doi.Org/10.1016/j.Arth.2016.01.052 on 9 february 2016.The reports upon follow ups for 43 patients and a table displays that 4 depuy pinnacle cups were utilized and 3 s-rom stems were utilized.Adverse events include: intraoperative femoral fracture (7), posterior dislocations (3) treated by closed reduction under general anesthesia, dvt (3) without treatment and symptoms gradually disappeared, thigh pain (4) that completely disappear after 2 years, groin pain which was aggravated by increased activity and radiographs reveal cup shifting and diagnosed as loosening (2).No further information provided if treatment or revision was provided for the cups diagnosed as loose, femoral osteolysis (9).The article does not clarify which adverse events are related to depuy products.

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 STEM
• Type of Device: HIP FEMORAL STEM
• 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: 9209568
• MDR Text Key: 173049053
• Report Number: 1818910-2019-108161
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• 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