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); Thrombosis (2100); Injury (2348); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article and guidance document attachment are too large for medwatch submission.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The literature article entitled, "cementless femoral revision arthroplasty 2 to 5 year results with a modular titanium alloy stem" written by jason a.Smith, md, harold k.Dunn, md, and b.J.Manaster, md published by the journal of arthroplasty vol.12 no.2 1997 was reviewed.The article's purpose was to review the results of a consecutive series of cementless femoral revisions that were followed prospectively.Data was compiled from revision surgeries between october 1988 to december 1991 with 35 male and 31 female patients with average age at time of surgery of 64.5 years.It is noted that the only depuy product utilized with srom femoral stem and all other components were non-depuy used in conjunction with the srom stem.The article reports generalized outcomes/adverse events and also identifies 2 patients with identifiers in radiographic images that are captured individually in linked complaints.Depuy products utilized: srom stem.This complaint captures the generalized adverse events: pain (no interventions clarified), radiographic findings of decreased femur bone density (no interventions clarified), intraoperative fractures in proximal and distal parts of femur during implantation (treated with cerclage wiring), intraoperative fractures caused by reamer (treated with cerclage wiring), post-op femur "secondary to fall" (no interventions clarified), dvt (no interventions clarified), vascular injury (no interventions clarified), exacerbation of congestive heart failure(no interventions clarified), peroneal nerve palsy(no interventions clarified), and superficial wound infection(no interventions clarified).

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.Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Per internal procedures, the event information was reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Investigational inputs were requested as indicated per internal procedures for this failure mode.Visual examination of the x-ray images provided on (b)(4) found no evidence of implant fracture, disassociation, or anything indicative of a device non-conformance.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9424587
• MDR Text Key: 185572332
• Report Number: 1818910-2019-120736
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 01/03/2020
• 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