MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 TRI-LOCK BPS SZ 0 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204005
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Test Result (2695); Not Applicable (3189)
Date of Event	10/10/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reporter is an attorney.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
Reason for original complaint-patient was revised to address infection.Pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported vomiting, flu-like symptoms, fever, severe pain, body aches, right hip infection, left hip effected mobility with sharp pains and soreness, fluid found in left hip, discomfort, unable to sit or stand for long periods of time, unable to exercise and do strenuous activities.Revision surgical report noted increased temperature and positive aspiration as reasons for revision.Ppf and sticker sheets received.In addition to what were previously alleged, ppf alleges pseudotumor, infection and metal wear/metallosis.Doi: (b)(6) 2010 - dor: (b)(6) 2012; (right hip).
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: TRI-LOCK BPS SZ 0 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7790790
• Report Number: 1818910-2018-66942
• Device Sequence Number: 19129718
• Product Code: KWA
• UDI-Device Identifier: 10603295000716
• UDI-Public: 10603295000716
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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 Expiration Date: 06/15/2020
• Device Catalogue Number: 101204005
• Device Lot Number: EX8DN1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: 52 YR
• Patient Weight: 31