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 Hemorrhage/Bleeding (1888)

Event Date 05/14/2016

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.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.(b)(4).

Event Description

"literature article entitled, ¿feasibility of day-case total hip arthroplasty: a single-centre observational study¿ by jens rolighed larsen, et al, published by hip international (2017), vol.27, no.1, pp.60-65, doi: 10.5301/hipint.5000421, was reviewed.The authors evaluated the feasibility, efficacy, safety and patient satisfaction of same-day (<12 hours) tha operation and discharge.29 consecutive patients were screened and 20 participated between october 2014 and january 2015.Depuy implants used: all patients were implanted with a depuy pinnacle cup and liner paired with a corail stem and depuy femoral head.Results: there were no reports of ami, dvt, insufficient analgesia, or circulatory instability.There were no reported reoperations or revision surgeries reported.There were no instances of infection, joint dislocation or readmissions at 6-week follow up.There was 1 reported intraoperative complication: an initiator drill broke and became embedded in the femoral bone and a wire cerclage needed to be inserted.No cabling was required.There were no long-term consequences and the patient had no postoperative complications.There was 1 reported case of a major bleed greater than 400 ml.Treatment was unknown.1 patient had postoperative nausea and received antiemetic medication in pacu.The patient had no long-term consequences and was complication free at 6-week follow-up.Captured in this complaint: pinnacle cup and liner, corail stem, femoral head, and unknown hip instrument.".

• 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 ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9328544
• MDR Text Key: 183040383
• Report Number: 1818910-2019-115854
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• 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: 10/25/2019
• 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