MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SOL SYS 10/16.5 R LRG STAT; STEM

Catalog Number	157211165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Weakness (2145)
Date of Event	07/30/2015
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
Pfs and medical records received.Pfs alleges infection, soreness, pain and discomfort, and device failure.After review of the medical records for mdr reportability, it was reported that the patient had cutaneous abscess.Clinical notes reported of fever, chills, weakness and cutaneous abscess.Doi: (b)(6) 2015.Dor: not revised (right hip).
Event or Problem Description
Ppf and medical records received.Ppf alleges infection after 1st revision.After review of medical records for mdr reportability,there is no revision notes reported.
Additional 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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SOL SYS 10/16.5 R LRG STAT
• Common Device Name: STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7084230
• Report Number: 1818910-2017-50805
• Device Sequence Number: 782936
• Product Code: LPH
• UDI-Device Identifier: 10603295061731
• UDI-Public: 10603295061731
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2017

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 157211165
• Device Lot Number: 426586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 04/10/2018; 07/27/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 05/02/2018; 08/07/2018
• 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: 64 YR
• Patient Weight: 132