MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 TRI-LOCK BPS SZ 7 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Catalog Number	101214070
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tissue Damage (2104); Test Result (2695); Not Applicable (3189)
Date of Event	07/10/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attorney.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
Litigation alleges that patient experienced serious physical injury, harm and damages.Doi: (b)(6) 2008 - dor: (b)(6) 2012; (right hip).Doi: (b)(6) 2009 - dor: (b)(6) 2012; (left hip).The sales rep has reported the revision surgery for the right side.Patient was revised to address increasing cobalt and chromium levels.Ppf and sticker sheets were received.Ppf alleges pseudotumor.The lawyer and law firm name are updated.Added stem for the previously alleges increasing cobalt and chromium levels.Doi: (b)(6) 2009 - dor: (b)(6) 2012; (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 will be filed as appropriate.

• Brand Name: TRI-LOCK BPS SZ 7 HI OFFSET
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7710052
• Report Number: 1818910-2018-64979
• Device Sequence Number: 906790
• Product Code: KWA
• UDI-Device Identifier: 10603295001096
• UDI-Public: 10603295001096
• Combination Product (Y/N): N
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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 Catalogue Number: 101214070
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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 Age: 55 YR
• Patient Weight: 109