MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 4 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204040
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
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.
Event or Problem Description
The tha surgery performed on (b)(6) 2019.It was reported that it was detected that a fracture around the stem (p/n: 101204040) and sinking the stem when the patient complained the pain after the tha surgery.Although there was a possibility for the revision surgery to be preformed by replacing the stem or wiring the femur, there was no information about additional surgery at the time of (b)(6) 2019.As dr¿s view: it was considered that the cause of fracture occurrence was the stem was might be too bigger than the tri-lock broach when compared.Possible cause: there was a possibility that the patient's femur was originally vulnerable due to osteoporosis and the like.No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.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 4 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8798601
• Report Number: 1818910-2019-98557
• Device Sequence Number: 3206189
• Product Code: KWA
• UDI-Device Identifier: 10603295000754
• UDI-Public: 10603295000754
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101204040
• Device Lot Number: J19P71
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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