MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 16D-SML; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number	550513
Date of Event	09/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
Total hip replacement: (b)(6) hospital.Primary (b)(6) 2016.Patient under went at total hip replacement in (b)(6) 2016, 6 months later he has unexplained pain in the joint, the surgeon first thought it was infected and treated the patient as per an infection.He had fluid collection, with high metal ions reported.The surgeon then thought it could be metallosis.A stage one revision for infection/metallosis was performed.The surgeon would like the prosthesis investigated to help with the reasoning as to what could event may have caused this issue.He would also like the prosthesis sent back to him, after depuy synthes has concluded their investigations, to send to dr (b)(6) for further analysis.
Additional Manufacturer Narrative
Pc(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).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
Update ad 12 nov 2018.Follow up information received that there was no metallosis, no infection and metals ions were within normal limits.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # = > (b)(4).Investigation summary = > the returned product was examined by a depuy material scientist.There is nothing outward to indicate product error or contribution to the reported problem.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, a follow-up medwatch will be filed as appropriate.

• Common Device Name: S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7918114
• Report Number: 1818910-2018-70783
• Device Sequence Number: 11330177
• Product Code: LPH
• UDI-Device Identifier: 10603295175230
• UDI-Public: 10603295175230
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K934412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2018

1 Device 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: 550513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 11/12/2018; 03/05/2019
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/18/2018; 12/03/2018; 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No