MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TRI-LOCK BPS SZ 2 HI OFFSET; HIP FEMORAL STEM

Catalog Number	101214020
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189); No Code Available (3191)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
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
Alleges the patient suffers from large amounts of toxic cobalt-chromium metal ions and particles to be released into the blood, tissue and bone, pain, discomfort and inflammation.
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 2 HI OFFSET
• Common Device Name: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7472522
• Report Number: 1818910-2018-58508
• Device Sequence Number: 1456488
• Product Code: KWA
• UDI-Device Identifier: 10603295001041
• UDI-Public: 10603295001041
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 03/02/2019
• Device Catalogue Number: 101214020
• Device Lot Number: DH1CY1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 12/24/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 88