MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT CEMENTED STEM SZ5 HI; HIP FEMORAL STEM

Catalog Number 157013110

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Test Result (2695); Not Applicable (3189); No Code Available (3191)

Event Date 04/12/2009

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Litigation alleges that patient experienced pain and discomfort, which negatively affected ability to perform activities of daily living.Blood tests have revealed consistently elevated levels of chromium and cobalt.Doi: (b)(6) 2004; dor: (b)(6) 2009; (left side).Pfs was received from legal, medical records were received from legal.Records are available for further review.Receipt of plaintiff profile form.Ppf alleges loosening of the stem at an unknown interface.Doi: (b)(6) 2004 : dor: (b)(6) 2009; (left hip).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint #: (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 CEMENTED STEM SZ5 HI
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7525270
• MDR Text Key: 108616558
• Report Number: 1818910-2018-59950
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

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: 05/25/2009
• Device Catalogue Number: 157013110
• Device Lot Number: YV2D61000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 04/18/2018; 08/29/2018
• Supplement Dates FDA Received: 05/18/2018; 09/20/2018
• Date Device Manufactured: 05/25/2004
• 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: 72 YR
• Patient Weight: 95