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 Thrombosis (2100)

Event Date 03/01/2016

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

Literature article entitled, ¿total hip arthroplasty (s rom stem) and subtrochanteric osteotomy for crowe type iv developmental dysplasia of the hip¿ by liangtao li, et al, published by the indian journal of orthopaedics (2016), vol.50, issue 2, pp.195-200 was reviewed for mdr reportability.The purpose of this study was to retrospectively evaluate the outcomes of subtrochanteric shortening osteotomy combined with tha using s-rom stem for those severe patients with a special focus on the effect of two shapes in the subtrochanteric osteotomy ends: oblique and transverse.Twenty-one cases with mean age of 43.6 years who met inclusion criteria and were operated between february 2007 and february 2012 were included in the study.Those cases had been divided into two groups (oblique vs.Transverse) and all records between the two groups were analyzed.All patients were treated with an s rom femoral stem including the cup, head, and augment (depuy).Cementless acetabular cup systems (depuy) were used in all patients except one cemented cup of unknown manufacturer.The mean diameter of the femur head was 25 mm (range 22¿28 mm).The average distal diameter of the stems was 11 mm (range 8¿13 mm).No nonunion of the osteotomy site were observed by the latest follow-up.There was no neurologic complication.No infection or loosening of the prosthesis was observed at the final follow-up.However, deep venous thrombosis developed in one case (case 3) and successfully managed by anti coagulants.One intraoperative crack of the distal segment happened in case 12 and treated with cerclage wires.Two dislocations (case 2 and 6) were encountered within 1 month postoperatively and managed with closed reduction under anesthesia.The authors provide detailed patient information in table 1, pp.197.There were 4 patients with operative complications or dislocations that required medical intervention.These patients are included within the guidance document labeled case 1-case 4.Case one is detailed within the parent (b)(4).Please link all associated pcs to (b)(4).(b)(6) year old female with bilateral tha.Developed deep vein thrombosis and was successfully treated with anticoagulants.No surgical intervention required.

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 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): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9117524
• MDR Text Key: 166047379
• Report Number: 1818910-2019-106120
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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: 11/27/2019
• 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
• Patient Age: 52 YR