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

Catalog Number	101204040
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
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
It was reported that the trilock femoral stem, size 4 lot # hr3366, is not good size.There is a manufacturing defect.Cat # 101204040, grm: 88363.The cmdsnet report number is: (b)(4), stem sz 4 std offset trilock hip - ah# (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.   h10 additional narrative: this is a duplicate report of 1818910-2019-96090.1818910-2019-99055 is being retracted as it a report duplication.1818910-2019-96090 will be kept for investigation purposes.

• Brand Name: TRI-LOCK BPS SZ 4 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8816722
• Report Number: 1818910-2019-99055
• Device Sequence Number: 327319
• Product Code: KWA
• UDI-Device Identifier: 10603295000754
• UDI-Public: 10603295000754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101204040
• Device Lot Number: HR3366
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1