MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Death (1802); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Injury (2348); Test Result (2695); No Code Available (3191)

Event Type  Death  

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.Device was used for treatment, not diagnosis.Initial reporter occupation: non-healthcare professional "attorney.".

Event Description

Asr litigation records received alleging feeling of heeling, headaches, pain, elevated blood chromium and cobalt levels, malaise, pressure fluctuations, injury, hypertension, coxalgia, walking difficulty and armd caused by erosion of the metal prosthetic components.It was indicated that the patient's blood cobalt levels were beyond 20 ug/l.Doi: (b)(6) 2010 - dor: not revised (left hip).

Manufacturer Narrative

Product complaint #
=
> (b)(4).Investigation summary
=
> no revision of the device has been reported and there was no allegation that the device was a contributor to this event.No explanted devices have been received in respect of this patient for analysis.Manufacturing records could not be reported as we were not provided with the product codes and lot numbers.If further information is received indicating that the device was a contributor or there is an alleged deficiency of the device then this event will be re-opened for evaluation.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. 1818910; 700 orthopaedic dr.; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN ; UK
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8623196
• MDR Text Key: 145478694
• Report Number: 1818910-2019-93948
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2019
• 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): Death; Other