MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ2 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011080

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Scarring (2061); Swelling (2091); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/09/2015

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.Udi: (b)(4).

Event Description

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation alleges that patient has experienced pain, injuries, and excessive levels of chromium and cobalt.Patient fact sheet was provided on 6/28/2012, which provided part/lot information.Update 8/4/16 medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing mdr decision.The complaint was updated on: 08/26/2016.Update 01/30/17 ¿ medical records received.After review of the medical records for mdr reportability, adding sleeve and stem due to previously alleged elevated metal ion levels.The complaint was updated on: 02/07/2017.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Litigation alleges that patient has experienced pain, injuries, and excessive levels of chromium and cobalt.Patient fact sheet was provided on (b)(6) 2012, which provided part/lot information.Update 8/4/16 medical records received.After review of the medical records for mdr reportability, there is no new additional information that would affect the existing mdr decision.Update 01/30/17 ¿ medical records received.After review of the medical records for mdr reportability, adding sleeve and stem due to previously alleged elevated metal ion levels.Update 02/07/17 ¿ medical records received.After review of the medical records for mdr reportability, a revision operative note was provided.The revision operative note indicated pain, metallosis and mechanical loosening, but there was no indication of what implant(s) were loose.The stem and cup were both noted to be fixed.There is no new additional information that would affect the existing mdr decision.

Event Description

Update jun 30, 2017: legal medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, it was stated that in the revision note that there was a scar measuring 7 cm.Clinical notes reported swelling, restricted rom, and walks with severe limp.This complaint was updated on: jul 10, 2017.

Manufacturer Narrative

New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation alleges that patient has experienced pain, injuries, and excessive levels of chromium and cobalt.Patient fact sheet was provided on (b)(6) 2012, which provided part/lot information.The reported event has been evaluated and will be monitored.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 SZ2 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: 6307539
• MDR Text Key: 66712147
• Report Number: 1818910-2017-12040
• 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,Followup,Followup
• Report Date: 01/30/2017

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: 157011080
• Device Lot Number: Z5PGG1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided; 06/30/2017; 01/09/2018
• Supplement Dates FDA Received: 02/13/2017; 07/11/2017; 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2005
• 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: 53 YR
• Patient Weight: 58