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

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440); Physical Asymmetry (4573)

Event Date 06/01/2019

Event Type  Injury  

Event Description

Literature article entitled: ¿modular and non-modular femoral prosthesis used in total hip arthroplasty comparative study of crowe type hip dysplasia,¿ by dou yong, et.Al., published in chinese journal of bone and joint surgery vol.12, no.6, jun.2019, doi: 10.3969/j.Issn.2095-9958.2019.06.06, was reviewed.Authors compared the clinical efficacy of total hip arthroplasty (tha) with modular s-rom femoral prosthesis and non-modular tri-lock femoral prosthesis in the treatment of crowe type ii developmental dysplasia of the hip (ddh).Eighty-seven patients were divided into two groups according to the type of femoral prosthesis: 42 cases in the modular group, using the s-rom prosthesis; 45 cases in the non-modular group, using the tri-lock prosthesis.All patients received pinnacle cups.The authors¿ conclusion was that for tha using either modular s-rom femoral prosthesis or non-modular tri-lock femoral prosthesis for crowe type ii ddh can achieve good clinical efficacy.However, use of the non-modular tri-lock prosthesis tha offers comparatively shorter operation time, less intraoperative blood loss and better limb length balance of lower limbs.Complications identified were: in s-rom group 1: calcar bone fracture (intraoperative).1: poor wound healing (required continuous dressing changes to treat).1: deep vein thrombosis, cured after conservative treatment.19: leg length discrepancy (>5mm) in tri-lock group.1: deep vein thrombosis, cured after conservative treatment.11: leg length discrepancy (>5mm).

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this reported event was not returned.Available x-ray evidence included in the study was reviewed.No failure of any depuy product can be observed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14876328
• MDR Text Key: 295068131
• Report Number: 1818910-2022-12122
• Device Sequence Number: 1
• Product Code: JDI
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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 HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 08/15/2022
• Supplement Dates FDA Received: 08/16/2022
• 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