MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 S-ROM*STM STD,30NK 14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Catalog Number	523291
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Der states that this patient had her right hip replaced recently and weeks after began to have some drainage from her wound.She had a consultation and hip aspiration which indicated there was most likely an infection present.Surgeon brought the patient to william beaumont troy for an i&d procedure.The hip ball, stem, and liner was explanted.The 48mm sector cup and srom sleeve was left implanted.The wound and joint was washed out and new components were implanted.Doi: (b)(6) 2018; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) 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.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7609161
• Report Number: 1818910-2018-62384
• Device Sequence Number: 19119143
• Product Code: MRA
• UDI-Device Identifier: 10603295170969
• UDI-Public: 10603295170969
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 523291
• Device Lot Number: 8641879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 89