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

Catalog Number 157001135

Device Problems Material Disintegration (1177); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Discomfort (2330); Test Result (2695); Not Applicable (3189); No Information (3190)

Event Date 10/11/2010

Event Type  Injury  

Event Description

Patient was revised to address hip pain.Update rec¿d 4/14/2014 - litigation papers received.In addition to what was previously reported, litigation alleges the patient suffers from discomfort and toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone.There is no new information that would affect the outcome of the investigation.Update 6/8/15-pfs and medical records received.After review of the medical records for mdr reportability, the revision operative note indicated pain.No labs were provided for the alleged high metal ions.The stem is being added to the complaint.

Manufacturer Narrative

His 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.

Manufacturer Narrative

No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what were previously alleged, ppf alleges pseudotumor, metallosis and metal wear.The stem was already added.Added lawyer and law firm.Doi: (b)(6) 2009 - dor: (b)(6) 2010 (right hip).(b)(4) for the second revision.

Manufacturer Narrative

(b)(4).Investigation summary no device associated with this report was received for examination.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.Depuy considers the investigation closed.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 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 4891553
• MDR Text Key: 6021422
• Report Number: 1818910-2015-25010
• 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: Other,consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup

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 Expiration Date: 10/27/2018
• Device Catalogue Number: 157001135
• Device Lot Number: C5GG11000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2015
• Initial Date FDA Received: 07/06/2015
• Supplement Dates Manufacturer Received: Not provided; 08/28/2018; 11/02/2018
• Supplement Dates FDA Received: 08/04/2015; 08/29/2018; 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2008
• 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: 47 YR
• Patient Weight: 82