MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 9 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Tri-lock bps femoral stem 12/14 taper size 9 std 113mm.Code 1012-04-090 lot 360212 q-ty- 1 (right implant).Date of implantation -(b)(6) 2013.Date of event (b)(6) 2018.Alert date - (b)(6) 2018 but hospital didn't provide event details long time.We received information in april,16.While moving up the stairs, the patient's implant broke the neck of the endoprosthesis in the right leg is broken (the femoral stem) adverse event, patient was hospitalized and carried out a revision in (b)(6) 2018.Now patient's condition is good.Product is available for return to lab.Doi: (b)(6) 2013; dor: (b)(6) 2018; right hip.
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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: 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. .

• Brand Name: TRI-LOCK BPS SZ 9 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7502089
• Report Number: 1818910-2018-59266
• Device Sequence Number: 284344
• Product Code: KWA
• UDI-Device Identifier: 10603295000808
• UDI-Public: 10603295000808
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101204090
• Device Lot Number: 360212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 10/18/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/11/2018; 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention