MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. TRI-LOCK BPS SZ 0 STD OFFSET; HIP FEMORAL STEM/SLEEVE

Catalog Number	101204005
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/30/2014
Type of Reportable Event	Malfunction
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
Clinical der states that the patient experienced an adverse event of leg length discrepancy.The event does not meet the definition of serious and is considered mild.The event is related to device and procedure.Event is currently not being treated.Update october 11, 2017: the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, despite extensive attempts to sink the femoral prosthesis more deeply, the femoral component seated approximately 5mm proximal to the targeted depth.The implant was found to be stable and it was determined that the operative leg would be lengthened approximately 3-5mm.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: TRI-LOCK BPS SZ 0 STD OFFSET
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6984299
• Report Number: 1818910-2017-27697
• Device Sequence Number: 423518
• Product Code: KWA
• UDI-Device Identifier: 10603295000716
• UDI-Public: 10603295000716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2017

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: 101204005
• Device Lot Number: 396296
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/08/2017
• 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: 48 YR
• Patient Weight: 61