MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL SYS 10/15.0 R LRG STAT; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Catalog Number	157211150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330)
Date of Event	12/05/2017
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 and muscle damage as a result of device failure and revision surgery.After review of the medical records for the mdr reportability, clinical notes reported of pain, discomfort and possible infection around the site.Doi: (b)(6) 2012; dor: not reported; right hip.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Udi: (b)(4).

• Brand Name: SOL SYS 10/15.0 R LRG STAT
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7164366
• Report Number: 1818910-2018-50218
• Device Sequence Number: 63119
• Product Code: LPH
• UDI-Device Identifier: 10603295061724
• UDI-Public: 10603295061724
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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: 08/31/2021
• Device Catalogue Number: 157211150
• Device Lot Number: 132909
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 07/31/2018; 12/14/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 08/27/2018; 12/19/2018
• 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: 58 YR
• Patient Weight: 150