MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 8 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
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.(b)(4).
Event or Problem Description
Patient present to surgeon rooms 3 years post total hip replacement with pain.On x-ray there was an area in the region of the distal portion of the stem where bone had was missing? reason.Revision surgery was performed.A frozen section was taken during the procedure which ruled out infection but still unknown cause.Stem was revised.Patient status / outcome / consequences? yes.Patient consequence description / was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? pain.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes.If yes, describe: revision surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 8 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9168945
• Report Number: 1818910-2019-108475
• Device Sequence Number: 19523816
• Product Code: KWA
• UDI-Device Identifier: 10603295001102
• UDI-Public: 10603295001102
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 101214080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: 80 YR