MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM STD36+21CR 22X17X165; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number 526682

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

Patient Problems Foreign Body Reaction (1868); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 08/29/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Medical record received.After review of medical record, patient was revised to address failed left hip arthroplasty consisting of a failed asr bearing with elevated metal ions.During implantation the calcar was cracked while inserting the sleeve.Revision notes reported that the patient had an area of fluid accumulation consistent with metallosis posterior to the joint.This was decompressed and debrided.The cable that had been placed was cut and removed.The head was disimpacted and removed the cup was freed up with minimal bone loss.

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

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 8803986
• MDR Text Key: 151479406
• Report Number: 1818910-2019-98706
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: 10603295171454
• UDI-Public: 10603295171454
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2009
• Device Catalogue Number: 526682
• Device Lot Number: 1183674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 07/23/2019
• Supplement Dates FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2004
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR