MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. UNKNOWN STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problems Corroded (1131); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Joint Swelling (2356); Osteolysis (2377); No Code Available (3191)

Event Date 07/16/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.See report for any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Patient suffered and/or will suffer pain, inhibition of the ability to walk, unnecessary and additional surgery, and other injuries presently undiagnosed.Update 12/7/15 medical records received.Medical records reviewed for mdr reportability.The revision surgical report dated (b)(6) 2015, noted that the patient hip made noises, patient had increasing serum cobalt and chromium levels, significant debris in the fluid, joint effusion, crepitation with flexion and internal rotation, impingement anterior neck, minimal metallosis, oxidation of the trunion and osteolysis.Unknown stem and sleeve added for the oxidation, hight metal ions, and impingement.

Manufacturer Narrative

The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.

• Brand Name: UNKNOWN STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5340609
• MDR Text Key: 34930334
• Report Number: 1818910-2016-10043
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2016
• 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: 66 YR