MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 SUMMIT POR TAPER SZ7 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011135

Device Problem Metal Shedding Debris (1804)

Patient Problems Edema (1820); Pain (1994); Toxicity (2333); Disability (2371); Osteolysis (2377)

Event Date 11/29/2012

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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

New etq record created in order to update etq (legacy system) (b)(4).Reason for original complaint ¿ litigation alleged the patient has suffered pain, disability, physical impairment, aggravation of a pre-existing condition and exposure to excessive levels of chromium and cobalt as a result of the implanted asr hip.Left hip: doi: (b)(6) 2008 - dor: none reported.Right hip: doi: (b)(6) 2009 - dor: none reported.*pt is a resident of (b)(6).**update** 12/27/2012 plaintiff fact sheet was received.The part/lot for right hip was updated.There is no new information that would change the outcome of the investigation.**update**(b)(6) 2013-sales rep reported revision surgery on left hip due to osteolysis.There was no new information that would change the outcome of the investigation.Dor: (b)(6) 2013 (left hip).Update 01/20/17 ¿ medical records received.After review of the medical records for mdr reportability, regarding the right hip, the revising surgeon indicated in his preoperative summary that the patient had elevated serum cobalt greater than 12 (no units given) and an mri demonstrating lateral fluid collection with abductor tendinopathy, but also no pain in the right hip.Added elevated metal ions harm and asr sleeve and stem to complaint.The complaint was updated on: 1/20/2017.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ7 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 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: 6292306
• MDR Text Key: 66235429
• Report Number: 1818910-2017-11729
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001991
• 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: 01/20/2017

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: 157011135
• Device Lot Number: DC9BE1000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2009
• 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: 74 YR