MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT POR TAPER SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011100

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)

Event Date 05/25/2018

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

Claim, medical records and sticker sheets received.After review of claim and medical records, it was stated that the patient was revised to address metallosis, pain and elevated cobalt levels.It was also stated that the stem was sitting very low and appeared to be subsided early on then ingrew.Revision notes reported that femoral component was noted to be well fixed and the femur was starting to form a crack.All components were removed.Doi: (b)(6) 2005 - dor: (b)(6) 2018 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ4 HI 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: kara ditty-bovard ; west chester; 19380, PA 46581-0988 ; 6103142063
• MDR Report Key: 8527137
• MDR Text Key: 142349907
• Report Number: 1818910-2019-91003
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295060055
• UDI-Public: 10603295060055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 157011100
• Device Lot Number: Z26GP1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 05/24/2019
• Supplement Dates FDA Received: 05/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2005
• 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: 49 YR