MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 6 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101204060
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Test Result (2695)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).
Event or Problem Description
Reason for original complaint: bilateral patient.Litigation alleges that patient experienced debilitating pain, discomfort, and soreness in the area of hip implant, thereby, negatively affecting ability to perform activities of daily living.Additionally, it is alleged that metal ions and particles have been released into patient's blood, tissue and bone surrounding the implant.Update ad 27 april 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets.There is no new allegation and revision reported.Added stem due to previously alleged metal ions and particles have been released into patient's blood.Added lawyer and law firm.Updated doi.Doi: (b)(6) 2010 - dor: not reported (left hip).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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 6 STD OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7866636
• Report Number: 1818910-2018-69024
• Device Sequence Number: 1980662
• Product Code: KWA
• UDI-Device Identifier: 10603295000778
• UDI-Public: 10603295000778
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 101204060
• Device Lot Number: DW9JV1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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 Weight: 73