MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 08/12/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Reason for original complaint- patient was revised to address acetabular loosening.Medical records were obtained.Medical records indicate patient was revised due to pain.Upon revision, mildly elevated metal ion levels, cloudy fluid, elevated sed rate and c-reactive protein, and a positive gram stain consistent with infection were found.Asr litigation records received alleging injury, economic loss, loss of services, pain, suffering and emotional distress.Doi: (b)(6) 2007; dor: none reported (right hip).There was no revision reported on the litigated records.However, previously received documents regarding this patient indicate that the patient had undergone revision on (b)(6) 2011.

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 meadwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ5 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9597916
• MDR Text Key: 186611116
• Report Number: 1818910-2020-02075
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295059363
• UDI-Public: 10603295059363
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1570-01-110
• Device Catalogue Number: 157001110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2020
• 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: 46 YR